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

Model Number UNKNOWN

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

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 (pc), concerned an (b)(6) female patient of han nationality.Medical history included hypertension and heart not good.Concomitant medication included acarbose and glargine (as reported), both for unknown indication.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injections (humulin 70/30) from cartridge via reusable pen (humapen unknown device), twice daily (morning and night), subcutaneously, for the treatment of diabetes mellitus, beginning on an unknown date (over a decade ago).On an unknown date in (b)(6) 2018, after starting human insulin isophane suspension 70%/human insulin 30% therapy, she was hospitalized due to poor control of blood glucose.During stay in hospital, she changed to use insulin lispro.Reportedly, the humapen had problem (pc 4286856, lot number unknown).Information regarding remaining corrective treatment, discharge details and outcome for the event was not provided.It was unknown that if the human insulin isophane suspension 70%/human insulin 30% therapy was restarted.Follow up was not possible as the reporter refused to follow up and physician contact details were not provided.The operator of the device and his/her training status were not provided.The humapen model duration of use and the suspect humapen duration of use was not provided but it was started since over 10 years ago.The action taken with the suspect humapen and its return status were not provided.The reporting consumer did not know if the event was related to human insulin isophane suspension 70%/human insulin 30% therapy and did not provide a relatedness assessment for the humapen.Edit 09mar2018: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Edit 11-mar-2018: upon review of the information initially received on 01-mar-2018, updated the suspect device coding from humapen ergo ii to humapen unknown device.Updated narrative accordingly.

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 (b)(6) 2018 in the b.5.Field.No further follow-up is planned.Evaluation summary: a female patient reported humapen (unspecified device) had a problem.The patient experienced abnormal blood glucose levels.The device was not returned to the manufacturer for investigation (batch unknown).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.All humapen 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 indicated the device was obtained 10 years ago.The humapen user manuals indicate the timeframe for which a device model has been designed to be used.Ten years exceeds the timeframe for any humapen model.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 event of abnormal blood glucose levels.

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 (pc), concerned an 80-years-old female patient of han nationality.Medical history included hypertension and heart not good.Concomitant medication included acarbose and glargine (as reported), both for unknown indication.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injections (humulin 70/30) from a cartridge via a reusable humapen (unknown) pen, twice daily (morning and night), subcutaneously, for the treatment of diabetes mellitus, beginning on an unknown date (over a decade ago).On an unknown date in (b)(6) 2018, after starting human insulin isophane suspension 70%/human insulin 30% therapy, she was hospitalized due to poor control of blood glucose.During stay in hospital, she changed to use insulin lispro.Reportedly, the humapen (unknown) pen had an unspecified problem ((b)(4), lot number unknown).Information regarding remaining corrective treatment, discharge details and outcome for the event was not provided.It was unknown that if the human insulin isophane suspension 70%/human insulin 30% therapy was restarted.Follow up was not possible as the reporter refused to follow up and physician contact details were not provided.The operator of the device and his/her training status were not provided.The humapen model duration of use and the suspect humapen duration of use was not provided but it was started since over 10 years ago.The suspect device was not returned to the manufacturer.The reporting consumer did not know if the event was related to human insulin isophane suspension 70%/human insulin 30% therapy and did not provide a relatedness assessment for the humapen (unknown) pen.Edit 09mar2018: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Edit 11-mar-2018: upon review of the information initially received on 01-mar-2018, updated the suspect device coding from humapen ergo ii to humapen unknown device.Updated narrative accordingly.Update 20mar2018: additional information received on 20mar2018 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 return to manufacturer for (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
• MDR Report Key: 7342021
• MDR Text Key: 102638246
• Report Number: 1819470-2018-00034
• 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,Followup
• Report Date: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 80 YR
• Patient Weight: 58