MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN LUXURA BURGUNDY; FOR TREATMENT PURPOSES

Model Number MS9662

Device Problems Crack (1135); Detachment of Device or Device Component (2907)

Patient Problems Diarrhea (1811); Fever (1858); Hyperglycemia (1905); Vomiting (2144)

Event Type  Injury  

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

Lilly case id: (b)(4).This report is associated with product compliant: (b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6)-year old asian male patient.Medical history was not provided.He had family history of diabetes mellitus.Concomitant medications were not provided.The patient received human insulin (rdna origin) injections (humulin specific type unknown, 100u/ml) from cartridge via reusable pen (humapen luxura, burgundy color), twice daily subcutaneously for the treatment of diabetes mellitus beginning in 1996 or 1997.On an unknown date, while on human insulin treatment, he sometimes had the problem of cold, sometimes the problem of foot injury, and once the problem of blood glucose.Since an unknown date in 1998 or 1999, he had been hospitalized sometimes due to the problem of foot injury, sometimes due to the problem of cold and once due to the problem of recuperation of blood glucose, every one or two years.On an unknown date, he experienced fever, diarrhea and vomiting which caused high blood glucose.In 2012-2013, he was hospitalized due to high blood glucose, fever, diarrhea and vomiting for therapy.After hospitalization, the human insulin was changed to insulin lispro 25 % insulin lispro protamine 75 % (rdna origin) injections (humalog mix 25, 100u/ml) subcutaneously for the treatment of diabetes mellitus according to a doctor advice.On an unknown date, while on insulin lispro 25 % insulin lispro protamine 75 %, he had been experiencing cold and foot injury.He had been hospitalized three to four times, sometimes was for having a cold and sometimes was for having foot injury.On an unknown date he had diabetes (diabetes mellitus inadequate control) and he was hospitalized in 2017 due to it.After hospitalized, his dose was changed from two times a day (morning 28 units, evening 36 units) to four times a day (morning 18 units, noon 18 units, afternoon 18 units, evening 14 units).Since on an unknown date, he had been experiencing heart diseases, hypertension and renal disease.Also, his height was shorter and shorter.On an unknown date, the trim ring of a humapen luxura burgundy was detached and the cartridge holder was cracked (pc-(b)(4), lot- 1006b03).He continued using the broken pen.As of (b)(6) 2019, his height of 168-169 cm.He had been using broken reusable device.Information regarding corrective treatment, outcome of the events and was not provided.Insulin lispro 25 % insulin lispro protamine 75 % treatment was continued.It was unknown if human insulin therapy would be restarted.The patient was the operator of the humapen luxura device and his training status was not provided.The humapen luxura, burgundy color model device duration of use and humapen luxura, burgundy color suspect device duration of use were not provided.The use of the suspect humapen luxura, burgundy color device was continued and its return status was not provided.The reporting consumer was not sure about any relatedness assessment between events and human insulin or insulin lispro 25 % insulin lispro protamine 75 % treatments.No assessment of relatedness provided between events and humapen luxura, burgundy color device.

Manufacturer Narrative

Narrative field: new, updated and corrected information is referenced within the update statements in b.5.Please refer to update statement dated (b)(6) 2019 in the b.5.Field.No further follow-up is planned.Evaluation summary a male patient reported that the cartridge holder of his humapen luxura device was cracked.He continued using the broken pen.He experienced abnormal and increased blood glucose.The device was not returned for investigation (batch 1006b03, manufactured june 2010).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.A complaint history review for the batch did not identify any atypical findings with regard to broken device cartridge holders or dose accuracy issues.The core instructions for use also states if any of the parts of your humapen luxura device appear broken or damaged, do not use.There is evidence of improper use.The patient continued to use the device after the alleged cartridge holder cracked issue.It is unknown if this misuse is be relevant to the events of abnormal and increased blood glucose.

Event Description

Lilly case id: (b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned a 61-year old asian male patient.Medical history was not provided.He had family history of diabetes mellitus.Concomitant medications were not provided.The patient received human insulin (rdna origin) injections (humulin specific type unknown, 100u/ml) from cartridge, via reusable pen (humapen luxura, burgundy color), twice daily subcutaneously for the treatment of diabetes mellitus beginning in 1996 or 1997.On an unknown date, while on human insulin treatment, he sometimes had the problem of cold, sometimes the problem of foot injury, and once the problem of blood glucose.Since an unknown date in 1998 or 1999, he had been hospitalized sometimes due to the problem of foot injury, sometimes due to the problem of cold and once due to the problem of recuperation of blood glucose, every one or two years.On an unknown date, he experienced fever, diarrhea and vomiting which caused high blood glucose.In 2012-2013, he was hospitalized due to high blood glucose, fever, diarrhea and vomiting for therapy.After hospitalization, the human insulin was changed to insulin lispro 25 % insulin lispro protamine 75 % (rdna origin) injections (humalog mix 25, 100u/ml) subcutaneously for the treatment of diabetes mellitus according to a doctor advice.On an unknown date, while on insulin lispro 25 % insulin lispro protamine 75 %, he had been experiencing cold and foot injury.He had been hospitalized three to four times, sometimes was for having a cold and sometimes was for having foot injury.On an unknown date he had diabetes (diabetes mellitus inadequate control) and he was hospitalized in 2017 due to it.After hospitalized, his dose was changed from two times a day (morning 28 units, evening 36 units) to four times a day (morning 18 units, noon 18 units, afternoon 18 units, evening 14 units).Since on an unknown date, he had been experiencing heart diseases, hypertension and renal disease.Also, his height was shorter and shorter.On an unknown date, the trim ring of a humapen luxura burgundy was detached and the cartridge holder was cracked(product complaint (b)(4) /lot number 1006b03).He continued using the broken pen.As of (b)(6) 2019 his height of 168-169cm.He had been using broken reusable device.Information regarding corrective treatment, outcome of the events and was not provided.Insulin lispro 25 % insulin lispro protamine 75 % treatment was continued.It was unknown if human insulin therapy would be restarted.The patient was the operator of the humapen luxura device and his training status was not provided.The humapen luxura, burgundy color model device duration of use and humapen luxura, burgundy color suspect device duration of use were not provided.The suspect humapen luxura (burgundy) device associated with product complaint (b)(4) was not returned to the manufacturer.The reporting consumer was not sure about any relatedness assessment between events and human insulin or insulin lispro 25 % insulin lispro protamine 75 % treatments.No assessment of relatedness provided between events and humapen luxura, burgundy color device.Edit 21aug2019: updated medwatch fields for expedited device reporting.No new information added.Update 30aug2019: additional information received on 29aug2019 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields with device information and the european and canadian (eu/ca) device information.Added date of manufacturer for the suspect humapen luxura (burgundy) device associated with product complaint (b)(4), which was not returned to the manufacturer.Corresponding fields and narrative updated accordingly.

• Brand Name: HUMAPEN LUXURA BURGUNDY
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• MDR Report Key: 8952162
• MDR Text Key: 161172084
• Report Number: 1819470-2019-00150
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K142518
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MS9662
• Device Lot Number: 1006B03
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/02/2019
• Initial Date FDA Received: 08/30/2019
• Supplement Dates Manufacturer Received: 08/29/2019
• Supplement Dates FDA Received: 09/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 61 YR
• Patient Weight: 65