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

Model Number MS9557

Device Problems Crack (1135); Application Program Problem: Dose Calculation Error (1189)

Patient Problems Hyperglycemia (1905); Itching Sensation (1943); Pain (1994)

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

(b)(4).This spontaneous case, reported by a consumer who contacted the company to report adverse events and product compliant, concerned a patient of unknown age and origin.Medical history was not reported.Concomitant medications included metformin for an unknown indication.The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) injections (humalog mix 25 100 u/ml) cartridge via unknown device and humapen ergo ii, 20 units in the morning, 20 units at noon, 32 units in the evening, three times a day, subcutaneously for the treatment of diabetes mellitus beginning on an unknown date in 2002.The patient started to receive humapen ergo ii (two tone blue) 3 ml from 2008 to (b)(6) 2018.On an unknown date in 2018, since starting insulin lispro protamine suspension 75%/insulin lispro 25% treatment, sight became bad/eyesight of the patient got worse.The patient was hospitalized due to overall body itch accompanied with high blood glucose (the blood glucose value was 18, 20 and more than 20) on (b)(6) 2018.The patient was also hospitalized due to the pain in the left thigh to knee in (b)(6) -2018 (the specific date was unknown).It was reported that the dose knob of a humapen ergo ii was cracked at the part which the dose knob was closed to the dose window in (b)(6) 2018, the dose was 20 at both morning and noon and 32 at night, but more than 10 units of insulin remained in the cartridge after it was used for 5 days which was caused by inaccurate dose due to the pen had malfunction (batch # 0805d01 and (b)(4)).Information regarding corrective treatment and outcome of the events was not provided.The status of insulin lispro protamine suspension 75%/insulin lispro 25% treatment was ongoing.The operator of the humapen ergo ii device was unknown and her training status was not provided.The humapen ergo ii device model duration was approximately 10 years and suspect humapen ergo ii device duration of use were not reported.The action taken with the suspect humapen ergo ii device was not provided and its return was expected.The reporting consumer did not know the relatedness assessment between the events and the insulin lispro protamine suspension 75%/insulin lispro 25% treatment.The reporting consumer did not provide the relatedness assessment between the events and humapen ergo ii device.Edit 05oct2018: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.

Event Description

Lilly case id: (b)(4).This spontaneous case, reported by a consumer who contacted the company to report adverse events and product compliant (pc), concerned a patient of unknown age and origin.Medical history was not reported.Concomitant medications included metformin for an unknown indication.The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) injections (humalog mix 25 100 u/ml) cartridge via unknown device and humapen ergo ii, 20 units in the morning, 20 units at noon, 32 units in the evening, three times a day, subcutaneously for the treatment of diabetes mellitus beginning on an unknown date in 2002.The patient started to receive humapen ergo ii (two tone blue) 3 ml from 2008 to (b)(6) 2018.On an unknown date in 2018, since starting insulin lispro protamine suspension 75%/insulin lispro 25% treatment, sight became bad/eyesight of the patient got worse.The patient was hospitalized due to overall body itch accompanied with high blood glucose (the blood glucose value was 18, 20 and more than 20) on (b)(6) 2018.It was reported that the dose knob of a humapen ergo ii was cracked at the part which the dose knob was closed to the dose window in (b)(6) 2018.The dose was 20 at both morning and noon and 32 at night, but more than 10 units of insulin remained in the cartridge after it was used for 5 days which was caused by inaccurate dose due to the pen had malfunction (batch 0805d01 and (b)(4)).The patient was also hospitalized due to the pain in the left thigh to knee in (b)(6) 2018 (the specific date was unknown).Information regarding corrective treatment and outcome of the events was not provided.The status of insulin lispro protamine suspension 75%/insulin lispro 25% treatment was ongoing.The operator of the humapen ergo ii device was unknown and her training status was not provided.The humapen ergo ii device model duration was approximately 10 years and suspect humapen ergo ii device duration of use were not reported.The suspect device, which was manufactured in may2008, was not returned to the manufacturer.The reporting consumer did not know the relatedness assessment between the events and the insulin lispro protamine suspension 75%/insulin lispro 25% treatment.The reporting consumer did not provide the relatedness assessment between the events and humapen ergo ii device.Edit 05oct2018: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 22oct2018: additional information received on 22oct2018 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch/european and canadian (eu/ca) device information, improper use and storage from no to yes, and device return status to returned to manufacturer.Added date of manufacturer for (b)(4) associated with lot number of 0805d01 of humapen ergo ii device.Corresponding fields and narrative updated accordingly.

Manufacturer Narrative

B.5.Narrative field: new, updated an corrected information is referenced within the update statements in b.5.Please refer to update statement dated 22oct2018 in the b.5.Field.No further follow-up is planned.Evaluation summary: a patient reported that the dose knob of their humapen ergo ii device was cracked and that the device was not delivering an accurate dose.The patient experienced increased blood glucose levels.The device was not returned to the manufacturer for investigation (batch number 0805d01, manufactured may 2008).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 findings with regard to device broken or dose accuracy issues.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.While it is unknown how long the patient used the device, based on the amount of time elapsed since the device was manufactured (may 2008), it is likely the patient used it beyond its approved use life.The user manual states the humapen ergo ii has been designed to be used for up to 3 years after first use.There is evidence of improper use.It is likely the patient used the device beyond its approved use life.This may be relevant to the increased blood glucose levels.

• 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: 7961583
• MDR Text Key: 123673493
• Report Number: 1819470-2018-00183
• 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: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS9557
• Device Lot Number: 0805D01
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization