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

Model Number MS9557

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Hyperglycemia (1905)

Event Date 05/31/2017

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 as necessary.

Event Description

(b)(4).This spontaneous case reported by a consumer who contacted the company to report adverse event and product complaint concerned a (b)(6) female patient of an unspecified origin.Medical history included not good enough liver function and hypertension.Concomitant medication included amlodipine besilate and acetylsalicylic acid, both for an unknown indication.The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) (humalog mix 25) cartridge via humapen ergo ii (bluish black), 12 units in the morning and 6 units in the night subcutaneously for the treatment of diabetes mellitus, beginning on (b)(6) 2015 (specific time was unknown).On an unspecified date in (b)(6) 2017, she had experienced high blood glucose which resulted in hospitalization.On (b)(6) 2018, she was injected 12 units and 4 units of insulin lispro protamine suspension 75%/insulin lispro 25% was not injected into (body) due to injection pen fault ((b)(4), lot no.1508d01).Information regarding corrective treatment was not provided.Outcome of the events was not provided.Treatment with insulin lispro protamine suspension 75%/insulin lispro 25% was continued.The operator of the humapen ergo ii and his/her training status were not provided.The humapen ergo ii model duration of use was not provided.The suspect humapen ergo ii duration of use was not reported.The action taken with the humapen ergo ii was continued and it was not returned.The reporting consumer did not know if the events were related to insulin lispro protamine suspension 75%/insulin lispro 25% treatment.The reporting consumer did not provide relatedness assessment between the events and humapen ergo ii.Edit 08feb2018: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.

Manufacturer Narrative

New updated and corrected information is referenced within the update statements.No further follow-up is planned.Evaluation summary: a female patient reported that in (b)(6) 2017, she had experienced high blood glucose which resulted in hospitalization.She further reported that on (b)(6) 2018, when using her humapen ergo ii device, she attempted to inject 12 units of insulin, and 4 units was not injected.There was no adverse event reported with the product complaint.The patient experienced increased blood glucose.The device was not returned to the manufacturer for investigation (batch number 1508d01, manufactured august 2015).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 device not working 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.There is no evidence of improper use or storage.

Event Description

Lilly case id: (b)(4).This spontaneous case reported by a consumer who contacted the company to report adverse event and product complaint concerned a 65-years-old female patient of an unspecified origin.Medical history included not good enough liver function and hypertension.Concomitant medication included amlodipine besilate and acetylsalicylic acid, both for an unknown indication.The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) (humalog mix 25) cartridge via humapen ergo ii (bluish black), 12 units in the morning and 6 units in the night subcutaneously for the treatment of diabetes mellitus, beginning on (b)(6) 2015 (specific time was unknown).On an unspecified date in (b)(6) 2017, she had experienced high blood glucose, which resulted in hospitalization.On (b)(6) 2018, she was injected 12 units, but 4 units of insulin lispro protamine suspension 75%/insulin lispro 25% was not injected into (body) due to injection pen fault.Further described, the humapen could be pushed down but no insulin flowed out, 4iu of insulin was not injected into body (conflicting onset date, end of (b)(6) 2018) (pc (b)(4), lot no.1508d01).Information regarding corrective treatment was not provided.Outcome of the events was not provided.Treatment with insulin lispro protamine suspension 75%/insulin lispro 25% was continued.The operator of the humapen ergo ii and his/her training status were not provided.The humapen ergo ii model duration of use was not provided.The suspect humapen ergo ii duration of use was not reported.The suspect humapen ergo ii associated with product complaint (b)(4) not returned to the manufacturer.The reporting consumer did not know if the events were related to insulin lispro protamine suspension 75%/insulin lispro 25% treatment.The reporting consumer did not provide relatedness assessment between the events and humapen ergo ii.Edit 08feb2018: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 02mar2018: additional information was received on 01mar2018 and 02mar2018 from the global product complaint database, which was processed together.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 humapen ergo ii device associated with product complaint (b)(4), which was not returned to the manufacturer.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: 7307957
• MDR Text Key: 101507852
• Report Number: 1819470-2018-00017
• 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: 03/14/2018

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MS9557
• Device Lot Number: 1508D01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/05/2018
• Initial Date FDA Received: 03/01/2018
• Supplement Dates Manufacturer Received: 03/01/2018
• Supplement Dates FDA Received: 03/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 65 YR
• Patient Weight: 50