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

Model Number UNKNOWN

Device Problem Mechanical Problem (1384)

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.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 along with product complaint, concerned a (b)(6) male patient of asian ethnicity.Medical history was not provided.Concomitant medications included insulin glargine for unknown indication.The patient received insulin lispro (rdna origin) (humalog, 100 iu/ml cartridge) via unknown reusable device (humapen unknown), three times daily (10 units in morning, 15 units in noon, 15 units in night) from unknown route for the treatment of diabetes mellitus beginning on an unknown date in 2000.On an unknown date after starting insulin lispro therapy, as the insulin lispro dosage was inaccurate (needed to inject 11 units but injected only 8 units) due to device issue ((b)(4)/ batch number- unknown), he was hospitalized to get his blood glucose adjusted (values and reference range not provided).More information regarding laboratory tests and hospitalization details was not provided.Corrective treatment and outcome of the events was not provided.Status of insulin lispro therapy was ongoing.The operator of the humapen was patient and his training status was not provided.The general and suspect humapen model duration of use was not provided as it was started on an unknown date in 2008.The action taken and return status with respect to suspect humapen was not provided.The reporting consumer was not sure whether the events were related to insulin lispro therapy or not.The reporting consumer did not provide relatedness assessment between the events and humapen device.Edit 26jul2018: 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 22aug2018 in the b.5.Field.No further follow-up is planned.Evaluation summary: a male patient reported that there were no clicking sounds when he pushed the injection button of his humapen (unspecified device).He reported the device was inaccurate, that it delivered 8 units instead of 11 units.The patient experienced abnormal blood glucose.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 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 along with product complaint (pc), concerned a 59- years- old male patient of asian ethnicity.Medical history was not provided.Concomitant medications included insulin glargine for unknown indication.The patient received insulin lispro (rdna origin) (humalog, 100 iu/ml cartridge) three times daily (10 units in morning, 15 units in noon, 15 units in night) from unknown route for the treatment of diabetes mellitus beginning on an unknown date in 2000.On an unknown date after starting insulin lispro therapy, via reusable humapen (unknown device), it was noted there was no clicking sounds when the injection button of the humapen was pushed and the dose was not accurate (needed to inject 11 units but injected only 8 units) (pc )(/ batch number unknown).He was hospitalized to get his blood glucose adjusted (values and reference range not provided) and it was noted he would injection insulin for three times (15iu at morning, noon, and evening) and would injection insulin glargine in the evening additionally (reported as a concomitant medication).More information regarding laboratory tests was not provided.Corrective treatment and outcome of the events was not provided.Status of insulin lispro therapy was ongoing.The operator of the humapen (unknown device) was the patient and his training status was not provided.Information on general and suspect device duration of use was not provided.The suspect humapen (unknown device) associated with product complaint (b)(4) was not returned to the manufacturer.The reporting consumer was not sure whether the events were related to insulin lispro therapy or not.The reporting consumer did not provide relatedness assessment between the events and humapen device.Edit 26jul2018: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 22aug2018: additional information received on 22aug2018 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 yes to no, and device age to unknown for the suspect humapen (unknown device) associated with product complaint (b)(4) , which was not returned to the manufacturer.Recoded concomitant humapen (unknown device) to concomitant humapen ergo ii.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: 7758831
• MDR Text Key: 116391307
• Report Number: 1819470-2018-00128
• 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: 09/13/2018

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/18/2018
• Initial Date FDA Received: 08/07/2018
• Supplement Dates Manufacturer Received: 08/22/2018
• Supplement Dates FDA Received: 09/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 59 YR
• Patient Weight: 72