MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN ERGO II; FOR TREATMENT PURPOSES

Model Number MS9557

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Syncope (1610); Hypoglycemia (1912); Unspecified Infection (1930); Loss of Vision (2139); Burning Sensation (2146); No Code Available (3191)

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 complaint: (b)(4).This solicited case, reported by a consumer via patient support program (psp), concerned a (b)(6) (at the time of initial report) female patient of an unspecified origin.Medical history included diabetes mellitus since 1999 and hypertension.Concomitant medication was not provided.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injections (humulin 70/30, 100u/ml) from unknown formulation via humapen ergo ii, of unknown dose, frequency, indication for use and route of administration beginning on an unknown date in 2004 or 2009 (conflicting start date).On an unknown date while on human insulin isophane suspension 70%/human insulin 30% therapy, due to diabetes mellitus (pre-existing) her sight had been lost.On an unknown date upon injection the humapen ergo ii left a bluish color in the area of injection.The event of diabetic blindness was considered as serious by the company due to medically significant reason.On an unknown date in 2011, while on the human insulin isophane suspension 70%/human insulin 30% she suffered from unspecified kidney disease.On an unknown date in 2014, she was suffering from the burning sensation and pus in urine.On an unknown date while being on teriparatide therapy she had kidney stone.Her kidney was collecting stones.On an unknown date in 2013, due to kidney stone, burning sensation in urine and urine pus, surgery was performed and one kidney was removed.She lived with one kidney.Two surgery was performed one in 2013 and the second followed it by two months.Second surgery was made as part of the kidney was not completely removed so her physician decidedly made the second surgery to remove it completely.On an unknown date while being on human insulin isophane suspension 70%/human insulin 30% therapy she had drop in blood glucose(values, units and reference ranges were not provided) so fainted sometimes accompanied by shivering.Event of burning sensation in urine, pus in urine, kidney stone, faint, blood glucose decreased and shivering was considered as serious by the company due to its medical significance reason.The information regarding the corrective treatment, outcome of events and status of human insulin isophane suspension 70%/human insulin 30% therapy was not provided.The operator of humapen ergo ii and his/her training status was not provided.General device and suspect device duration should be approximately 10 years.The action taken of humapen ergo ii was not provided and if it was returned, evaluation would be performed to determine if a malfunction had occurred.The initial reporting consumer did not provide the relatedness of events to human insulin isophane suspension 70%/human insulin 30% therapy and to humapen ergo ii.Update 12-jun-2019: additional information was received from initial reporter via psp on 09-jun-2019.Updated therapy start date as conflicting 2004 and 2009.Added a lab data of blood glucose decreased, medical history, serious event of pus in urine, kidney stone, burning sensation in urination, faint, blood glucose decreased, shivering and added non serious event of kidney disease.Updated narrative with new information.Edit 19jun2019: updated medwatch and european and (b)(4) (eu/(b)(4)) fields for expedited device reporting.No new information added.

Manufacturer Narrative

B.5.Narrative field: new, updated and corrected information is referenced within the update statements in b.5.Please refer to update statement dated 15jul2019 in the b.5.Field.No further follow-up is planned.Evaluation summary: the husband of a female patient reported the dose button of the patient's humapen ergo ii device is stiff and does not release insulin easily, and that the pen body is broken.He also reported that the device left a bluish color in the area of injection.The patient experienced decreased blood glucose.The investigation of the returned device (batch 0803d08, manufactured march 2008) found the pen housing and bezel were cracked.The device could not be function tested because of the damage.The cracks in the body are consistent with damage that occurred while in the field.In addition, foreign material was observed on the dial, the dialing screw and the drive sleeve.Malfunction confirmed.All humapen ergo ii 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 core user manual states that the injection button may become harder to push if the inside of the pen gets dirty with insulin, food, drink or other materials.Following the care and storage instructions should help prevent this.The reported also stated the device had been used for approximately ten years.The core user manual states the humapen ergo ii device has been designed to be used for up to 3 years after first use.There is evidence of improper use.The device was contaminated with foreign material while in the field and the patient used the device beyond its approved use life it is unknown if these misuses are relevant to the event of decreased blood glucose.

Event Description

Lilly case id: (b)(4).This solicited case, reported by a consumer via patient support program (psp), concerned a 56-year-old (at the time of initial report) female patient of an unspecified origin.Medical history included diabetes mellitus since 1999 and hypertension.Concomitant medication was not provided.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injections (humulin 70/30, 100u/ml) from unknown formulation via a reusable humapen ergo ii device, of unknown dose, frequency, indication for use and route of administration beginning on an unknown date in 2004 or 2009 (conflicting start date).On an unknown date while on human insulin isophane suspension 70%/human insulin 30% therapy, due to diabetes mellitus (pre-existing) her sight had been lost.On an unknown date, upon injection the humapen ergo ii left a bluish color in the area of injection.The event of diabetic blindness was considered as serious by the company due to medically significant reason.On an unknown date in 2011, while on the human insulin isophane suspension 70%/human insulin 30% she suffered from unspecified kidney disease.On an unknown date in 2014, she was suffering from the burning sensation and pus in urine.On an unknown date while being on therapy she had kidney stone.Her kidney was collecting stones.On an unknown date in 2013, due to kidney stone, burning sensation in urine and urine pus, surgery was performed and one kidney was removed.She lived with one kidney.Two surgery was performed one in 2013 and the second followed it by two months.Second surgery was made as part of the kidney was not completely removed so her physician decidedly made the second surgery to remove it completely.On an unknown date while being on human insulin isophane suspension 70%/human insulin 30% therapy she had drop in blood glucose(values, units and reference ranges were not provided) so fainted sometimes accompanied by shivering.Event of burning sensation in urine, pus in urine, kidney stone, faint, blood glucose decreased and shivering was considered as serious by the company due to its medical significance reason.It was noted that the pen dose button was stiff and did not release insulin easily.In addition, the grey part of the pen was broken and they did put the pen in the fridge (lot 0803d08/product complaint (b)(4)).The information regarding the corrective treatment, outcome of events and status of human insulin isophane suspension 70%/human insulin 30% therapy was not provided.The operator of humapen ergo ii and his/her training status was not provided.General device and suspect device duration should be approximately 10 years.The suspect device, which was manufactured in mar2008, was returned to the manufacturer on 04jun2019.The initial reporting consumer did not provide the relatedness of events to human insulin isophane suspension 70%/human insulin 30% therapy and to humapen ergo ii.Update 12-jun-2019: additional information was received from initial reporter via psp on 09-jun-2019.Updated therapy start date as conflicting 2004 and 2009.Added a lab data of blood glucose decreased, medical history, serious event of pus in urine, kidney stone, burning sensation in urination, faint, blood glucose decreased, shivering and added non serious event of kidney disease.Updated narrative with new information.Edit 19jun2019: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 15jul2019: additional information received on 15jul2019 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields/european and canadian (eu/ca) device information, malfunction from unknown to yes/not cirm, and device return status to returned to manufacturer.Added date of manufacturer and date returned to manufacturer for the device with (b)(4) associated with lot 0803d08 of humapen ergo ii.Corresponding fields and narrative updated accordingly.

• Brand Name: HUMAPEN ERGO II
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• MDR Report Key: 8748614
• MDR Text Key: 149655154
• Report Number: 1819470-2019-00118
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K151686
• 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: 08/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS9557
• Device Lot Number: 0803D08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2019
• Date Manufacturer Received: 07/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR