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

Model Number MS9557

Device Problems Failure to Advance (2524); Device Operates Differently Than Expected (2913)

Patient Problem Hyperglycemia (1905)

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 events and product compliant (pc), concerned a (b)(6) female patient of (b)(6) nationality.Medical history included primary hypertension, diabetic nephropathy, left pituitary gland had tubercle and current pregnancy.Drug adverse reaction history and family drug adverse reaction were none.She used unspecified insulin for less than one month during pregnancy.Concomitant medication included metformin and probucol for unknown indication.The patient received insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) injections (humalog mix 50, 100 u/ml) from cartridge via reusable device (humapen ergo ii), twice daily (16 units in morning and 14 units in night), subcutaneously, for the treatment of gestational diabetes mellitus beginning from (b)(6) 2017.The date of her last menstrual period and estimate due date (edd) were not provided.The manufacturer had estimated a due date of (b)(6) 2018.The mother began insulin lispro protamine suspension 50%/insulin lispro 50% at unknown weeks of pregnancy.On an unknown date after starting insulin lispro protamine suspension 50%/insulin lispro 50% therapy, she experienced high blood glucose for which she was hospitalized in (b)(6)2018.In (b)(6) 2018, humapen ergo ii could not be pushed down and the injection screw could not move ((b)(4)/ lot number 1611d02).Information regarding corrective treatment, hospitalization details and outcome for the events was not provided.Insulin lispro protamine suspension 50%/insulin lispro 50% therapy was ongoing.The operator of the humapen ergo ii and his/ her training status were not provided.The humapen ergo ii model duration of use and suspect humapen ergo ii duration of use were not provided but it was started since (b)(6) 2017.The action taken with the suspect humapen ergo ii and its return status was not provided.The reporting consumer did not know if the events were related to insulin lispro protamine suspension 50%/insulin lispro 50% and did not provide a relatedness assessment for the events to humapen ergo ii.The exposure event was captured for tracking purpose.Edit 25may2018: updated medwatch and european and canadian (eu/ca) 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 11jun2018 in the b.5.Field.No further follow-up is planned.Evaluation summary: a female patient reported that in (b)(6) 2018, the injection button of her humapen ergo ii device could not be pushed and the injection screw could not move.Prior to the device issue, in (b)(6) 2018, the patient experienced increased blood glucose.The device was not returned to the manufacturer for investigation (batch number 1611d02, manufactured november 2016).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 pen jam 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 events and product compliant (pc), concerned a 30-years-old female patient of han nationality.Medical history included primary hypertension, diabetic nephropathy, left pituitary gland had tubercle and current pregnancy.Drug adverse reaction history and family drug adverse reaction were none.She used unspecified insulin for less than one month during pregnancy.Concomitant medication included metformin and probucol for unknown indication.The patient received insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) injections (humalog mix 50, 100u/ml) from cartridge via a reusable humapen ergo ii device, twice daily (16 units in morning and 14 units in night), subcutaneously, for the treatment of gestational diabetes mellitus beginning from (b)(6) 2017.The date of her last menstrual period and estimate due date (edd) were not provided.The manufacturer had estimated a due date of (b)(6) 2018.The mother began insulin lispro protamine suspension 50%/insulin lispro 50% at unknown weeks of pregnancy.On an unknown date after starting insulin lispro protamine suspension 50%/insulin lispro 50% therapy, she experienced high blood glucose for which she was hospitalized in (b)(6) 2018.In (b)(6) 2018, humapen ergo ii could not be pushed down and the injection screw did not move ((b)(4)/ lot number 1611d02).Information regarding corrective treatment, hospitalization details and outcome for the events was not provided.Insulin lispro protamine suspension 50%/insulin lispro 50% therapy was ongoing.The operator of the humapen ergo ii and his/ her training status were not provided.The humapen ergo ii model duration of use and suspect humapen ergo ii duration of use were not provided but it was started since (b)(6) 2017; approximately seven months.The suspect humapen ergo ii, which was manufactured in nov2016, was not returned to the manufacturer.The reporting consumer did not know if the events were related to insulin lispro protamine suspension 50%/insulin lispro 50% and did not provide a relatedness assessment for the events to humapen ergo ii.The exposure event was captured for tracking purpose.Edit 25may2018: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 12jun2018: additional information received on 11jun2018 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch/european and canadian (eu/ca) device information and device return status to not returned to manufacturer.Added date of manufacturer for (b)(4) associated with lot 1611d02 of humapen ergo ii device.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: 7566702
• MDR Text Key: 110071246
• Report Number: 1819470-2018-00099
• 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: 06/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS9557
• Device Lot Number: 1611D02
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 30 YR
• Patient Weight: 57