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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN LUXURA CHAMPAGNE; FOR TREATMENT PURPOSES
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ELI LILLY AND COMPANY HUMAPEN LUXURA CHAMPAGNE; FOR TREATMENT PURPOSES Back to Search Results
Model Number MS9663
Device Problems Break (1069); Leak/Splash (1354)
Patient Problems Hyperglycemia (1905); Pain (1994); Visual Impairment (2138)
Event Date 02/29/2016
Event Type  Injury  
Manufacturer Narrative
If device is returned, evaluation will be performed to determine if a malfunction has occurred.A follow-up report will be submitted when the final evaluation is completed.
 
Event Description
(b)(4).This spontaneous case, reported by a consumer who contacted the company to report an adverse event with a product complaint, concerns an elderly caucasian female patient who was (b)(6).The medical history of patient included diabetes since approximately 2009.The concomitant medications included losartan, simvastatin and metformin, all of them for unknown indications.The patient received human insulin nph (rdna origin) (humulin n) cartridge via reusable pen, unknown dose and frequency, subcutaneously, for treatment of diabetes, beginning approximately in (b)(6) 2015.On an unspecified date, unknown time after the starting of human insulin nph, the patient experienced a pain in the shoulder of unknown cause and her physician prescribed an unspecified corticoid for ten days as corrective treatment.Approximately in (b)(6) 2016 reported as in the 8th day of corticoid treatment, seven months after the starting of human insulin nph, the patient felt very unwell but she completed the corticoid treatment.It was unknown if she received corrective treatment for feeling unwell.Information regarding outcome of pain in the shoulder and feeling unwell was not provided.In (b)(6) 2016, approximately seven months after the starting of human insulin nph via humapen luxura champagne, the unspecified corticoid caused dysregulated glycemia described as glycemia was very high after the corticoid treatment and it reached the value of 500 mg/dl.As corrective measure the physician increased the dose of human insulin nph to 20 iu to be used three times per day (at morning, at lunch and at night).The event of high glycemia was considered serious by the company due to medically significant reason.It was also provided that patient did not see properly due to the high diabetes (as reported) in (b)(6) 2016 and in the previous days close to initial report from (b)(6) 2016 her vision was weaker.The patient did not receive corrective treatment for weak vision and she was recovering from this event and from the high glycemia.On (b)(6) 2016 at night the patient noted that insulin was leaking and the cartridge was broken and then she looked for the injection screw which jumped out (as reported) of the humapen luxura champagne (lot number 0903b02; (b)(4)) and it was broken.It was also provided that everything was burst, it was unknown how the injection screw had fallen and the patient always reutilized the needles.Treatment with human insulin nph was continued.The patient operated the device and she was trained by a physician.The patient had used the device model and the reported device for less than one year.The device return was expected and if device is returned, evaluation will be performed to determine if a malfunction has occurred.The reporting consumer considered the event of high glycemia related to human insulin nph and did not know if the event of weak vision was related to human insulin nph.A relatedness opinion between human insulin nph and the remaining events was not provided.The reporting consumer also stated that the event of high glycemia was due to the use of unspecified corticoid and that the weak vision was caused by the high diabetes (as reported).(b)(4).Edit 28mar2016: upon internal review on 28mar2016 a non-medically significant edit was completed in order to include in narrative the number of product complaint associated to humapen luxura champagne (lot number 0903b02).Update 29mar2016.Case was opened to enter medwatch device fields for device mailing.
 
Manufacturer Narrative
Evaluation summary: a female patient experienced a serious adverse event of increased blood glucose in (b)(6) 2016.On 15 march 2016, the patient reported the injection screw on her humapen luxura device was broken and the insulin cartridge was broken.The device was not returned for investigation (batch 0903b02, manufactured march 2009).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.A complaint history review of this batch did not identify any atypical trends with regard to dose accuracy.All humapen luxura devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality and dose accuracy.Based on the timeline of when the serious adverse event of increased blood glucose occurred and the injection screw broken was reported, it is unlikely that the defect was related to the serious adverse event.There is evidence of improper use.The patient reused needles and did not hold the injection button 5 seconds which may be relevant to the complaint of increased blood glucose.
 
Event Description
(b)(4).This spontaneous case, reported by a consumer who contacted the company to report an adverse event with a product complaint, concerns an elderly caucasian female patient who was born in 1949.The medical history of patient included diabetes since approximately 2009.The concomitant medications included losartan, simvastatin and metformin, all of them for unknown indications.The patient received human insulin nph (rdna origin) (humulin n) cartridge via reusable pen, unknown dose and frequency, subcutaneously, for treatment of diabetes, beginning approximately in (b)(6) 2015.On an unspecified date, unknown time after the starting of human insulin nph, the patient experienced a pain in the shoulder of unknown cause and her physician prescribed an unspecified corticoid for ten days as corrective treatment.Approximately in (b)(6) 2016 reported as in the 8th day of corticoid treatment, seven months after the starting of human insulin nph, the patient felt very unwell but she completed the corticoid treatment.It was unknown if she received corrective treatment for feeling unwell.Information regarding outcome of pain in the shoulder and feeling unwell was not provided.In (b)(6) 2016, approximately seven months after the starting of human insulin nph via humapen luxura champagne, the unspecified corticoid caused dysregulated glycemia described as glycemia was very high after the corticoid treatment and it reached the value of 500 mg/dl.As corrective measure the physician increased the dose of human insulin nph to 20 iu to be used three times per day (at morning, at lunch and at night).The event of high glycemia was considered serious by the company due to medically significant reason.It was also provided that patient did not see properly due to the high diabetes (as reported) in (b)(6) 2016 and in the previous days close to initial report from (b)(6) 2016 her vision was weaker.The patient did not receive corrective treatment for weak vision and she was recovering from this event and from the high glycemia.On (b)(6) 2016 at night the patient noted that insulin was leaking and the cartridge was broken and then she looked for the injection screw which jumped out (as reported) of the humapen luxura champagne (lot number 0903b02; product complaint (b)(4)) and it was broken.It was also provided that everything was burst, it was unknown how the injection screw had fallen and the patient always reutilized the needles.Treatment with human insulin nph was continued.The patient operated the device and she was trained by a physician.The patient had used the device model and the reported device for less than one year.The device was not returned.The reporting consumer considered the event of high glycemia related to human insulin nph and did not know if the event of weak vision was related to human insulin nph.A relatedness opinion between human insulin nph and the remaining events was not provided.The reporting consumer also stated that the event of high glycemia was due to the use of unspecified corticoid and that the weak vision was caused by the high diabetes (as reported).This case is cross-referenced to case (b)(4).Edit 28mar2016: upon internal review on 28mar2016 a non-medically significant edit was completed in order to include in narrative the number of product complaint associated to humapen luxura champagne (lot number 0903b02).Update 29mar2016.Case was opened to enter medwatch device fields for device mailing.Update 19apr2016.Additional information received 18apr2016 from the product complaint safety database.To the device tab added the device specific safety summary (dsss), updated the european and canadian (eu/ca) device information, updated the medwatch device information, and the narrative was updated accordingly.Edit 19apr2016.Corrected the medically significant received date to 18apr2016.Update 25apr2016: additional information received on 22apr2016 from the global product complaint database updated the device specific safety summary.
 
Manufacturer Narrative
Evaluation summary: a female patient experienced a serious adverse event of increased blood glucose in (b)(6) 2016.On 15 march 2016, the patient reported the injection screw on her humapen luxura device was broken and the insulin cartridge was broken.The investigation of the returned device (batch 0903b02, manufactured march 2009) found glass remnants inside the housing of the device.Due to the glass remnants, the injection screw would not back drive and the cartridge holder would not attach to the device.No additional functional testing was possible because of the glass.Malfunction confirmed.A complaint history review of this batch did not identify any atypical trends with regard to dose accuracy.All humapen luxura devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality and dose accuracy.Based on the timeline of when the serious adverse event of increased blood glucose occurred and the injection screw broken was reported, it is unlikely that the defect was related to the serious adverse event.There is evidence of improper use.The patient reused needles and did not hold the injection button 5 seconds which may be relevant to the complaint of increased blood glucose.
 
Event Description
(b)(4).This spontaneous case, reported by a consumer who contacted the company to report an adverse event with a product complaint, concerns an elderly caucasian female patient who was born in 1949.The medical history of patient included diabetes since approximately 2009.The concomitant medications included losartan, simvastatin and metformin, all of them for unknown indications.The patient received human insulin nph (rdna origin) (humulin n) cartridge via reusable pen, unknown dose and frequency, subcutaneously, for treatment of diabetes, beginning approximately in (b)(6) 2015.On an unspecified date, unknown time after the starting of human insulin nph, the patient experienced a pain in the shoulder of unknown cause and her physician prescribed an unspecified corticoid for ten days as corrective treatment.Approximately in (b)(6) 2016 reported as in the 8th day of corticoid treatment, seven months after the starting of human insulin nph, the patient felt very unwell but she completed the corticoid treatment.It was unknown if she received corrective treatment for feeling unwell.Information regarding outcome of pain in the shoulder and feeling unwell was not provided.In (b)(6) 2016, approximately seven months after the starting of human insulin nph via humapen luxura champagne, the unspecified corticoid caused dysregulated glycemia described as glycemia was very high after the corticoid treatment and it reached the value of 500 mg/dl.As corrective measure the physician increased the dose of human insulin nph to 20 iu to be used three times per day (at morning, at lunch and at night).The event of high glycemia was considered serious by the company due to medically significant reason.It was also provided that patient did not see properly due to the high diabetes (as reported) in (b)(6) 2016 and in the previous days close to initial report from 16mar2016 her vision was weaker.The patient did not receive corrective treatment for weak vision and she was recovering from this event and from the high glycemia.On (b)(6) 2016 at night the patient noted that insulin was leaking and the cartridge was broken and then she looked for the injection screw which jumped out (as reported) of the humapen luxura champagne (lot number 0903b02; product complaint (b)(4)) and it was broken.It was also provided that everything was burst, it was unknown how the injection screw had fallen and the patient always re utilized the needles.Treatment with human insulin nph was continued.The patient operated the device and she was trained by a physician.The patient had used the device model and the reported device for less than one year.The device returned on 26apr2016.The reporting consumer considered the event of high glycemia related to human insulin nph and did not know if the event of weak vision was related to human insulin nph.A relatedness opinion between human insulin nph and the remaining events was not provided.The reporting consumer also stated that the event of high glycemia was due to the use of unspecified corticoid and that the weak vision was caused by the high diabetes (as reported).This case is cross-referenced to case (b)(4).Edit 28mar2016: upon internal review on 28mar2016 a non-medically significant edit was completed in order to include in narrative the number of product complaint associated to humapen luxura champagne (lot number 0903b02).Update 29mar2016.Case was opened to enter medwatch device fields for device mailing.Update 19apr2016.Additional information received 18apr2016 from the product complaint safety database.To the device tab added the device specific safety summary (dsss), updated the european and canadian (eu/ca) device information, updated the medwatch device information, and the narrative was updated accordingly.Edit 19apr2016.Corrected the medically significant received date to 18apr2016.Update 25apr2016: additional information received on 22apr2016 from the global product complaint database updated the device specific safety summary.Update 23aug2016.Additional information received on 22aug2016 from the global product complaint database.On the device tab updated the device specific safety summary, updated the european and canadian (eu/ca) device information, updated the medwatch device information, and the narrative was updated accordingly.
 
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Brand Name
HUMAPEN LUXURA CHAMPAGNE
Type of Device
FOR 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 Key5540778
MDR Text Key41650148
Report Number1819470-2016-00073
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K142518
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Type of Report Initial,Followup,Followup
Report Date 03/16/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberMS9663
Device Lot Number0903B02
Was Device Available for Evaluation? Yes
Date Manufacturer Received08/22/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/31/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
SIMVASTATIN
Patient Outcome(s) Other;
Patient Age67 YR
Patient Weight75
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