MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN, UNKNOWN DEVICE; FOR TREATMENT PURPOSES

Model Number UNKNOWN

Device Problem Use of Device Problem (1670)

Patient Problems Hearing Loss (1882); Hypoglycemia (1912)

Event Date 10/31/2018

Event Type  Injury  

Manufacturer Narrative

New, updated and corrected information is referenced within the update statements.Please refer to update statement dated (b)(6) 2018.No further follow-up is planned.Evaluation summary: a male patient reported that the dose window of his humapen ergo ii device was blurred.He experienced hypoglycemia.The device was not returned for investigation (batch unknown).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.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 patient reported the device was used for more than 14 years.The core instructions for use states the device was designed to be used for up to 3 years after first use.There is evidence of improper use.The patient used the device beyond its approved use life.It is unknown if this is relevant to the complaint of dose window blurred or the event of hypoglycemia.

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This spontaneous case, reported by a consumer who contacted the company to report adverse events and a product complaint (pc), with additional information from initial reporter, concerned a male patient of unknown age and origin.Medical history included heart disease and his kidney was not good.Concomitant medications included acarbose for unspecified indication.The patient received an unspecified form of insulin lispro family (rdna origin) injections (humalog) from cartridge, via a reusable humapen (unknown device type) subcutaneously, for treatment of diabetes, beginning in 2004; dose and frequency were not provided.He also received insulin lispro protamine suspension 75%/ insulin lispro 25% (rdna origin) injections (humalog mix25) from cartridge via a reusable humapen (unknown device type), twice a day, 16 units in the morning and 8 units at night, subcutaneously, for the treatment of diabetes mellitus, beginning in 2004.Since an unknown date, after starting insulin lispro and lispro protamine suspension 75%/ insulin lispro 25%, his ears were not good; he became deaf.The event of deaf was considered as serious due to its medical significance.Since an unknown date, the dose window of his humapen was blurred and the soft touch was peeling off (associated pc (b)(4)/ lot number unknown).It was noted that the device was used 14 years.On an unspecified date in (b)(6) 2018, while on insulin lispro and lispro protamine suspension 75%/ insulin lispro 25% therapies, he was hospitalized due to hypoglycemia (no glucose values, units or reference range provided) for three days.Hospitalization details included admission and discharge dates, corrective treatment or laboratory examination findings were not provided.Information regarding corrective treatment and event outcome was not provided.Insulin lispro and lispro protamine suspension 75%/ insulin lispro 25% therapies were ongoing.The user of the device and his/her training status was not provided.The device model duration of use was not provided; suspect device duration of use was about 14 years.The suspect device was not returned to the manufacturer.The reporting consumer did not provide an assessment of relatedness between the hypoglycemia event and insulin lispro therapy and did not know if it was related to insulin lispro protamine suspension 75%/ insulin lispro 25% therapy.The reporting consumer did not know if the deafness event was related to any insulin therapy.The reporting consumer did not provide an assessment of relatedness between the events and suspect device.Update (b)(6) 2018: additional information was received from the reporting consumer on (b)(6) 2018.Added medical history, insulin lispro protamine suspension 75%/ insulin lispro 25% as co-suspect drug, added the serious event of hypoglycemia.Updated description as reported of the deafness event.Updated concomitant device to suspect device.Updated narrative accordingly.Update (b)(6) 2018: additional information was received from the responsible complaint person (rcp) on (b)(6) 2018.Pc reference number was processed; added device details (color and age, updated return status: not expected).Updated narrative accordingly.Update (b)(6) 2018: additional information received on (b)(6) 2018.No new medically significant information provided.No other changes made to the case.Edit (b)(6) 2018: upon review of information received on (b)(6) 2018, suspect drug was updated from insulin lispro to unspecified form of insulin lispro; hospitalization duration was removed, added three days as part of the event details.Updated narrative accordingly.Update (b)(6) 2018: additional information received on (b)(4) 2018 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields with device information, the european and canadian (eu/ca) device information, improper use and storage from no to yes, and device return status to not returned to manufacturer for pc (b)(4) associated with unknown lot of a humapen unknown device.Corresponding fields and narrative updated accordingly.

• Brand Name: HUMAPEN, UNKNOWN DEVICE
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• Manufacturer (Section G): PHILLIPS-MEDISIZE CORPORATION; 415 red cedar street; medical device manufacturing; menomonie WI 54751
• Manufacturer Contact: chris davis ; lilly corporate center; indianapolis, IN 46285 ; 3174334585
• MDR Report Key: 8154877
• MDR Text Key: 130049692
• Report Number: 1819470-2018-00211
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial
• Report Date: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization