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U.S. Department of Health and Human Services

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

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ELI LILLY AND COMPANY SAMPLE HUMAPEN LUXURA HALF-DOSE PEN FOR TREATMENT PURPOSES Back to Search Results
Model Number MS9675
Device Problems Device Inoperable (1663); High Readings (2459)
Patient Problems Abdominal Pain (1685); Hyperglycemia (1905); Virus (2136); Weight Changes (2607)
Event Date 07/21/2017
Event Type  Injury  
Manufacturer Narrative
New updated and corrected information is referenced within the update statements. Please refer to statement dated 15nov2017. No further follow up is planned. Evaluation summary: the reporter stated the patient stored the humapen luxura half dose (hd) in the refrigerator and generally only uses one new needle per day for three to four injections. There was no product complaint for the device and the device was not returned for investigation. There was evidence of improper use and storage of the device. The patient stored the humapen luxura hd in the refrigerator and generally only uses one needle per day for three to four injections. The user manual states do not store the humapen luxura hd in a refrigerator and to use a new needle with each injection to ensure sterility, prevent leakage of insulin, keep out air bubbles, and reduce needle clogs.
 
Event Description
Lilly case id: (b)(4). This spontaneous case, reported by a consumer to report adverse events, concerned a (b)(6) male patient of unspecified age and origin. Medical history included very insulin sensitive. He had used insulin lispro (vials) for diabetes type 1 since 2009 or 2010. Concomitant medications were not provided. The patient received insulin lispro (rdna origin) (humalog, 100 u/ml) through a cartridge via reusable pen (humapen luxura hd, up to 3-4 times per day on a 20:1 carb ratio and glucose ratio of 75:1, for the treatment of type one diabetes, beginning on (b)(6) 2017. Since starting insulin lispro (via luxura hd) he felt insulin lispro (a batch of insulin cartridges) was not working like it should have worked. He had exceedingly high blood sugars and it would go up and up, and the insulin just was not working. He had a couple of days where his blood sugars were up to 400-500-600 (units were not provided), and he kept taking the insulin, and he could not figure out why it was going up. He ended up in the hospital [(b)(6) 2017-(b)(6) 2017], and they gave him insulin glargine in the hospital and his blood sugar came down (conflicting information regarding hospitalization as the later this hospitalization was considered because of some sort of virus). His sugar went back up when he got out of the hospital and went back to using the insulin lispro. Eventually he used one of the insulin glargine pens provided at the hospital and it came right down. When he tried the insulin lispro pen again the next day, his blood sugar went right back up. On (b)(6) 2017 it was 559 by 5:00 pm, and he took a whole bunch of insulin, way more than he normally would, and it was still 250. On (b)(6) 2017, in the evening it was so high the meter just read high. He used insulin glargine that night and the next day and his sugar came down, but it went right back up when he started using insulin lispro again on (b)(6) 2017 and in the morning his sugar was 600 and all he had was a cup of coffee. He had spoken with his endocrinologist regarding his elevated blood sugars and stated that his doctor gave him a two week glucose monitor that was stuck on his arm. He had this experience with every cartridge of insulin lispro he had used with the luxura hd device since he began using both around (b)(6) 2017. He had used insulin lispro from a total of three different cartridges during that time. He had stored both unopened and in-use cartridge/luxura device in the refrigerator. The insulin in the three reported cartridges was clear, colorless, and particle-free and had not been exposed to temperatures less than 32°f or more than 86°f. He generally only used one needle per day (for 3-4 injections. ) the insulin lispro vials used in the past had always worked appropriately to control his blood sugar. According to him he had been hospitalized due to some sort of virus, and he was really sick to stomach. He lost 17 pounds in two days. He went from (b)(6). The event of weight loss and blood sugar increased was considered as serious due to other medical significance. He had recovered from the virus and was not yet fully recovered from the weight loss but had regained some of the weight. He also stated that his fingers were getting sore. Information regarding other corrective treatment was not provided. Outcome of the event pain in finger was recovering and outcome for remaining event was not provided. Insulin lispro treatment was continued. The user of the humapen luxura hd was patient and his training status was not provided. The humapen luxura hd general duration of use and the suspect humapen luxura hd device duration of use was one day. The humapen luxura hd was not returned to the manufacturer. The reporting consumer considered the event blood glucose increased as related to insulin lispro. The reporting consumer did not provide relatedness assessment between the event incorrect storage and insulin lispro. The reporting consumer considered the remaining events as not related to insulin lispro treatment. The reporting consumer considered the events as not related to humapen luxura hd. The reporting consumer related the event pain in finger to increased frequency of blood glucose testing and not related to the use of insulin lispro. Update 03oct2017: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting. No new information added. Update 15nov2017: updated medwatch, european and (b)(6) (eu/(b)(6)) fields, and device available for evaluation from yes to no; entered a device specific safety summary (dsss); and added the unique device identifier (udi) number for the suspect humapen luxura half dose (hd). 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.
 
Event Description
(b)(4). Product compliant: pending. This spontaneous case, reported by a consumer to report adverse events, concerned a (b)(6) male patient of unspecified age and origin. Medical history included very insulin sensitive. He had used insulin lispro (vials) for diabetes type 1 since 2009 or 2010. Concomitant medications were not provided. The patient received insulin lispro (rdna origin) (humalog, 100 u/ml) through a cartridge via reusable pen (humapen luxura hd, up to 3-4 times per day on a 20:1 carb ratio and glucose ratio of 75:1, for the treatment of type one diabetes, beginning on (b)(6) 2017. Since starting insulin lispro (via luxura hd) he felt insulin lispro (a batch of insulin cartridges) was not working like it should have worked. He had exceedingly high blood sugars and it would go up and up, and the insulin just was not working. He had a couple of days where his blood sugars were up to 400-500-600 (units were not provided), and he kept taking the insulin, and he could not figure out why it was going up. He ended up in the hospital [(b)(6) 2017], and they gave him insulin glargine in the hospital and his blood sugar came down (conflicting information regarding hospitalization as the later this hospitalization was considered because of some sort of virus). His sugar went back up when he got out of the hospital and went back to using the insulin lispro. Eventually he used one of the insulin glargine pens provided at the hospital and it came right down. When he tried the insulin lispro pen again the next day, his blood sugar went right back up. On (b)(6) 2017 it was 559 by 5:00 pm, and he took a whole bunch of insulin, way more than he normally would, and it was still 250. On (b)(6) 2017, in the evening it was so high the meter just read high. He used insulin glargine that night and the next day and his sugar came down, but it went right back up when he started using insulin lispro again on (b)(6) 2017 and in the morning his sugar was 600 and all he had was a cup of coffee. He had spoken with his endocrinologist regarding his elevated blood sugars and stated that his doctor gave him a two week glucose monitor that was stuck on his arm. He had this experience with every cartridge of insulin lispro he had used with the luxura hd device since he began using both around (b)(6) 2017. He had used insulin lispro from a total of three different cartridges during that time. He had stored both unopened and in-use cartridge/luxura device in the refrigerator. The insulin in the three reported cartridges was clear, colorless, and particle-free and had not been exposed to temperatures less than 32°f or more than 86°f. He generally only used one needle per day (for 3-4 injections. ) the insulin lispro vials used in the past had always worked appropriately to control his blood sugar. According to him he had been hospitalized due to some sort of virus, and he was really sick to stomach. He lost 17 pounds in two days. He went from 146 pounds to 129 pounds. The event of weight loss and blood sugar increased was considered as serious due to other medical significance. He had recovered from the virus and was not yet fully recovered from the weight loss but had regained some of the weight. He also stated that his fingers were getting sore. Information regarding other corrective treatment was not provided. Outcome of the event pain in finger was recovering and outcome for remaining event was not provided. Insulin lispro treatment was continued. The user of the humapen luxura hd was patient and his training status was not provided. The humapen luxura hd general duration of use and the suspect humapen luxura hd device duration of use was one day. The action taken with the suspect humapen luxura hd was not provided and its return was not expected. The reporting consumer considered the event blood glucose increased as related to insulin lispro. The reporting consumer did not provide relatedness assessment between the event incorrect storage and insulin lispro. The reporting consumer considered the remaining events as not related to insulin lispro treatment. The reporting consumer considered the events as not related to humapen luxura hd. The reporting consumer related the event pain in finger to increased frequency of blood glucose testing and not related to the use of insulin lispro. Update 03oct2017: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting. No new information added.
 
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Brand NameSAMPLE HUMAPEN 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 Key6915158
MDR Text Key269367950
Report Number1819470-2017-00182
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K063151
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/05/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMS9675
Device Catalogue NumberMS9675
Device Lot Number1603G03
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/15/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 10/05/2017 Patient Sequence Number: 1
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