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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN LUXURA HALF-DOSE PEN FOR TREATMENT PURPOSES

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ELI LILLY AND COMPANY HUMAPEN LUXURA HALF-DOSE PEN FOR TREATMENT PURPOSES Back to Search Results
Model Number MS9673A
Device Problems Improper Flow or Infusion (2954); Mechanical Jam (2983)
Patient Problems Malaise (2359); Missed Dose (2561); Foreign Body In Patient (2687)
Event Date 01/30/2017
Event Type  Injury  
Manufacturer Narrative
Narrative field; new updated and corrected information is referenced within the update statements in describe event or problem. This report is associated with 1819470-2017-00031 and 1819470-2017-00032, since there is more than one device implicated. No further follow up is planned. A male patient reported that when using his humapen luxura hd device the injection screw broke loose from device, the device "started to become stiff to inject insulin," that it was not possible to attach the insulin cartridges in the device, and insulin leaks out after the application. The patient's physician indicated the device was jammed. The patient experienced diabetic ketoacidosis. The actual sequence of the alleged malfunctions is unknown. Investigation of the returned device (batch number 1401g10, manufactured january 2014) found that the injection screw was broken. Tool marks and glass present inside the front housing indicate the damage occurred in the field. A functional assessment could not be performed. The damage to the device, including the presence of glass, rendered the device unusable. The user manual instructs to not use the device if it appears broken or damaged and to contact lilly or your healthcare professional for a replacement pen. A complaint history review for the batch did not identify any atypical findings with respect to cartridge insertion / attachment, device is not accurate, injection force high, injection screw broken, leaking after injection from injection site, or pen jam. The user manual states if any of the parts of your humapen luxura hd appear broken or damaged, do not use. Improper use and storage - there is evidence of improper use. The tool marks on the device occurred while in the field (not related to the manufacturing process). The patient continued to use the device after experiencing problems. It is unknown if these issues are relevant to the event of diabetic ketoacidosis.
 
Event Description
(b)(4). This spontaneous case, reported by a consumer, who contacted the company to report an adverse event, with additional information reported by a second reporting consumer, who contacted the company to report an adverse event and a product complaint, concerns a male patient of unknown age and origin. As medical history, patient had diabetes. The concomitant medications were not reported. Patient received human insulin (rdna origin) nph (humulin n) cartridge, three times a day with doses of 10 iu, 10 iu and 8 iu, at unspecified route of administration, for unspecified indication, beginning the treatment on unknown date. Patient also received human insulin (rdna origin) regular (humulin r) unknown formulation, three times a day with doses of 21 iu, 9 iu and 13 iu, at unspecified route of administration, for unspecified indication, beginning the treatment on unknown date. It was not reported how human insulin regular was delivered. On unknown date, unspecified time frame after the beginning of the treatment with human insulin nph via humapen luxura hd and human insulin regular, patient experienced diabetic ketoacidosis. Due to that, patient was hospitalized on (b)(6) 2017. Patient spent four days in the semi intensive care and two days in the nursery, being discharged on (b)(6) 2017. The physician of the patient told him that the event was probably caused by the lack of injection of human insulin nph as the devices were jammed. It was informed that the patient bought three humapen luxura hd devices and none of them worked, soon they jammed and did not inject the insulin (lot number 1401g10 / (b)(4); lot number 1401g10 / (b)(4); and lot number 1312g01 / (b)(4)). On unknown date, patient had to inject insulin three times and on (b)(6) 2017 the last pen broke. It was reported that the devices started to fail; they got hard to inject insulin. The pen was maintained in the skin for one or two minutes and when it was removed, the insulin was released outside the skin. The laboratorial exams were not reported. As a corrective measure, patient bought two humapen savvio devices. Patient was recovering from the adverse events. Therapy status with human insulin nph and human insulin regular was not reported. It was unknown who operated the devices and if the operator was trained. It was unknown how long the patient had used this device model and the reported devices. Humapen luxura hd with lot 1401g10 associated with (b)(4) was returned to manufacture on 05apr2017; return status of the other pens were not provided. The reporting consumer did not provide any opinion of relatedness. Update 07feb2017: this case was initially determined to be non-valid (unknown product). Additional information was received on 06feb2017 from second reporting consumer. It was added human insulin nph and human insulin regular as suspect products, humapen luxura hd from lot numbers unknown, c304087 and c315120 as suspect devices; it was added non-serious event of drug dose omission, event of malaise was updated to diabetic ketoacidosis and it was added dates of hospitalization and discharge. Narrative and corresponding fields were updated accordingly. Edit 08feb2017: upon review it was noticed that the event of drug dose omission was lacking in the update of 07feb2017. Update 08feb2017: upon review, the case was opened to update the medwatch and european and canadian required device reporting elements for regulatory reporting. Update 08feb2017: additional information received on 08feb2017 from global product complaint database updated the lot number from c315120 to 1312g01for (b)(4). The product tab for humapen luxura hd and the narrative were updated. Update 09feb2017: additional information was received on 08feb2017 from the initial reporting consumer. It was updated the lot number from c304087 to 1401g10 for (b)(4). The product tab for humapen luxura hd and the narrative were updated. Update 09feb2017: additional information received on 08feb2017 from global product complaint database updated the lot number from unknown to 1401g10 for (b)(4). The product tab for humapen luxura hd and the narrative were updated. Edit 16feb2017: upon review, it was noticed that the information that the patient used the three devices that jammed was not clear; therefore, narrative was updated. Update 28feb2017. Additional information received 27feb2017 from the product complaint safety database. On the 3 suspect device tabs entered the manufacturer date,device specific safety summaries (dsss), updated the european and canadian (eu/ca) device information, updated the medwatch field with the device information and the narrative was updated accordingly. Edit 28apr2017. Medically significant was not selected for the date of 28feb2017 and was now completed. Update 07jun2017: additional information received on 06jun2017 from the global product complaint database. Entered device specific safety summary (dsss) for the device associated with (b)(4). Updated the medwatch fields with device information, the european and canadian (eu/ca) device information, and changed device available for evaluation from no to returned to manufacturer. Added date returned to manufacturer for the device on 05apr2017. Corresponding fields and narrative updated accordingly.
 
Manufacturer Narrative
If device is returned, evaluation will be performed to determine if a malfunction has occurred. This is an initial report. A follow-up report will be submitted when the final evaluation is completed. This report is associated with 1819470-2017-00031 and 1819470-2017-00032, since there is more than one device implicated.
 
Event Description
(b)(4). This spontaneous case, reported by a consumer, who contacted the company to report an adverse event, with additional information reported by a second reporting consumer, who contacted the company to report an adverse event and a product complaint, concerns a male patient of unknown age and origin. As medical history, patient had diabetes. The concomitant medications were not reported. Patient received human insulin (rdna origin) nph (humulin n) cartridge, three times a day with doses of 10 iu, 10 iu and 8 iu, at unspecified route of administration, for unspecified indication, beginning the treatment on unknown date. Patient also received human insulin (rdna origin) regular (humulin r) unknown formulation, three times a day with doses of 21 iu, 9 iu and 13 iu, at unspecified route of administration, for unspecified indication, beginning the treatment on unknown date. It was not reported how human insulin regular was delivered. On unknown date, unspecified time frame after the beginning of the treatment with human insulin nph via humapen luxura hd and human insulin regular, patient experienced diabetic ketoacidosis. Due to that, patient was hospitalized on (b)(6) 2017. Patient spent four days in the semi intensive care and two days in the nursery, being discharged on (b)(6) 2017. The physician of the patient told him that the event was probably caused by the lack of injection of human insulin nph as the devices were jammed. It was informed that the patient bought three humapen luxura hd devices and none of them worked, soon they jammed and did not inject the insulin (lot number 1401g10, (b)(4), lot number 1401g10, (b)(4) and lot number 1312g01, (b)(4)). On unknown date, patient had to inject insulin three times and on (b)(6) 2017 the last pen broke. It was reported that the devices started to fail; they got hard to inject insulin. The pen was maintained in the skin for one or two minutes and when it was removed, the insulin was released outside the skin. The laboratorial exams were not reported. As a corrective measure, patient bought two humapen savvio devices. Patient was recovering from the adverse events. Therapy status with human insulin nph and human insulin regular was not reported. It was unknown who operated the devices and if the operator was trained. It was unknown how long the patient had used this device model and the reported devices. Return status of the pens was not provided. The reporting consumer did not provide any opinion of relatedness. Update 07feb2017: this case was initially determined to be non-valid (unknown product). Additional information was received on 06feb2017 from second reporting consumer. It was added human insulin nph and human insulin regular as suspect products, humapen luxura hd from lot numbers unknown, c304087 and c315120 as suspect devices; it was added non-serious event of drug dose omission, event of malaise was updated to diabetic ketoacidosis and it was added dates of hospitalization and discharge. Narrative and corresponding fields were updated accordingly. Edit 08feb2017: upon review it was noticed that the event of drug dose omission was lacking in the update of 07feb2017. Update 08feb2017: upon review, the case was opened to update the medwatch and european and canadian required device reporting elements for regulatory reporting. Update 08feb2017: additional information received on 08feb2017 from global product complaint database updated the lot number from c315120 to 1312g01 for (b)(4). The product tab for humapen luxura hd and the narrative were updated. Update 09feb2017: additional information was received on 08feb2017 from the initial reporting consumer. It was updated the lot number from c304087 to 1401g10 for (b)(4). The product tab for humapen luxura hd and the narrative were updated. Update 09feb2017: additional information received on 08feb2017 from global product complaint database updated the lot number from unknown to 1401g10 for (b)(4). The product tab for humapen luxura hd and the narrative were updated. Edit 16feb2017: upon review, it was noticed that the information that the patient used the three devices that jammed was not clear; therefore, narrative was updated.
 
Manufacturer Narrative
New updated and corrected information is referenced within the update statements in describe event or problem. This report is associated with 1819470-2017-00031 and 1819470-2017-00032, since there is more than one device implicated. Evaluation summary from device, the device "started to become stiff to inject insulin," that it was not possible to attach the insulin cartridges in the device, and insulin leaks out after the application. The patient's physician indicated the device was jammed. The patient experienced diabetic ketoacidosis. The device was not returned for investigation (batch number 1401g10, manufactured january 2014). Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction. Malfunction unknown. The actual sequence of the alleged malfunctions is unknown. A broken injection screw or the inability to attach an insulin cartridge would render the device unusable, which is inconsistent with the other issues. A complaint history review for the batch did not identify any atypical findings with respect to cartridge insertion / attachment, device is not accurate, injection force high, injection screw broken, leaking after injection from injection site, or pen jam. All humapen luxura hd devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality and dose accuracy with high probability. The user manual states if any of the parts of your humapen luxura hd appear broken or damaged, do not use. There is evidence of improper use. The patient continued to use the device after experiencing problems. It is unknown if these issues are relevant to the event of diabetic ketoacidosis.
 
Event Description
(b)(4). This spontaneous case, reported by a consumer, who contacted the company to report an adverse event, with additional information reported by a second reporting consumer, who contacted the company to report an adverse event and a product complaint, concerns a male patient of unknown age and origin. As medical history, patient had diabetes. The concomitant medications were not reported. Patient received human insulin (rdna origin) nph (humulin n) cartridge, three times a day with doses of 10 iu, 10 iu and 8 iu, at unspecified route of administration, for unspecified indication, beginning the treatment on unknown date. Patient also received human insulin (rdna origin) regular (humulin r) unknown formulation, three times a day with doses of 21 iu, 9 iu and 13 iu, at unspecified route of administration, for unspecified indication, beginning the treatment on unknown date. It was not reported how human insulin regular was delivered. On unknown date, unspecified time frame after the beginning of the treatment with human insulin nph via humapen luxura hd and human insulin regular, patient experienced diabetic ketoacidosis. Due to that, patient was hospitalized on (b)(6) 2017. Patient spent four days in the semi intensive care and two days in the nursery, being discharged on (b)(6) 2017. The physician of the patient told him that the event was probably caused by the lack of injection of human insulin nph as the devices were jammed. It was informed that the patient bought three humapen luxura hd devices and none of them worked, soon they jammed and did not inject the insulin (lot number 1401g10, (b)(4), lot number 1401g10, (b)(4) and lot number 1312g01, (b)(4)). On unknown date, patient had to inject insulin three times and on (b)(6) 2017 the last pen broke. It was reported that the devices started to fail; they got hard to inject insulin. The pen was maintained in the skin for one or two minutes and when it was removed, the insulin was released outside the skin. The laboratorial exams were not reported. As a corrective measure, patient bought two humapen savvio devices. Patient was recovering from the adverse events. Therapy status with human insulin nph and human insulin regular was not reported. It was unknown who operated the devices and if the operator was trained. It was unknown how long the patient had used this device model and the reported devices. Return status of the pens was not provided. The reporting consumer did not provide any opinion of relatedness. Update 07feb2017: this case was initially determined to be non-valid (unknown product). Additional information was received on 06feb2017 from second reporting consumer. It was added human insulin nph and human insulin regular as suspect products, humapen luxura hd from lot numbers unknown, c304087 and c315120 as suspect devices; it was added non-serious event of drug dose omission, event of malaise was updated to diabetic ketoacidosis and it was added dates of hospitalization and discharge. Narrative and corresponding fields were updated accordingly. Edit 08feb2017: upon review it was noticed that the event of drug dose omission was lacking in the update of 07feb2017. Update 08feb2017: upon review, the case was opened to update the medwatch and european and canadian required device reporting elements for regulatory reporting. Update 08feb2017: additional information received on 08feb2017 from global product complaint database updated the lot number from c315120 to 1312g01 for (b)(4). The product tab for humapen luxura hd and the narrative were updated. Update 09feb2017: additional information was received on 08feb2017 from the initial reporting consumer. It was updated the lot number from c304087 to 1401g10 for (b)(4). The product tab for humapen luxura hd and the narrative were updated. Update 09feb2017: additional information received on 08feb2017 from global product complaint database updated the lot number from unknown to 1401g10 for (b)(4). The product tab for humapen luxura hd and the narrative were updated. Edit 16feb2017: upon review, it was noticed that the information that the patient used the three devices that jammed was not clear; therefore, narrative was updated. Update 28feb2017. Additional information received 27feb2017 from the product complaint safety database. On the 3 suspect device tabs entered the manufacture date,device specific safety summaries (dsss), updated the european and canadian (eu/ca) device information, updated the medwatch field with the device information and the narrative was updated accordingly. Edit 28apr2017. Medically significant was not selected for the date of 28feb2017 and was now completed.
 
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Brand NameHUMAPEN LUXURA HALF-DOSE PEN
Type of DeviceFOR TREATMENT PURPOSES
Manufacturer (Section D)
ELI LILLY AND COMPANY
lilly corporate center
indianapolis IN 46285
Manufacturer (Section G)
PHILLIPS-MEDISIZE CORPORATION
medical device manufacturing
415 red cedar street
menomonie WI 54751
Manufacturer Contact
caroline rosewell
lilly corporate center
indianapolis, IN 46285
3172764376
MDR Report Key6356255
MDR Text Key117020413
Report Number1819470-2017-00030
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K063151
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Type of Report Initial,Followup,Followup
Report Date 05/01/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/24/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberMS9673A
Device Lot Number1401G10
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/05/2017
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/06/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/31/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/24/2017 Patient Sequence Number: 1
Treatment
HUMULIN REGULAR; INSULIN HUMAN NPH
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