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

Model Number MS9557

Device Problem Mechanical Jam (2983)

Patient Problem Hyperglycemia (1905)

Event Date 01/31/2015

Event Type  Injury  

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This spontaneous case, reported by a consumer via a company representative, concerns a (b)(6) male patient of unknown ethnicity.Medical history of patient and concomitant medications were not provided.The patient received 70% human insulin nph and 30% human insulin regular (rdna origin) (humulin 70/30) cartridge via humapen ergo ii, unknown dose and frequency, subcutaneously, for the treatment of diabetes mellitus, beginning on an unknown date.On an unknown date, unclear if before or after starting 70% human insulin nph and 30% human insulin regular, patient was hospitalized for an unknown reason, and on an unspecified date around 2015 (as reported) patient was hospitalized due to diabetes mellitus.Reporter informed that patient used two different pens.In the first pen the injection button could not be pushed down in around (b)(6) 2021 (lot number 0906d04; product complaint number 5670593), and in the second pen the injection button was pushed down to the end without clicking sounds in around (b)(6) 2021, and also the injection screw did not move, and reporter informed that it was slipping and no insulin came out (lot number 1303d01; product complaint number (b)(4)).Information regarding hospitalization details, exams, corrective treatment and outcome of the event was unknown.It was unknown if any action was taken with 70% human insulin nph and 30% human insulin regular due to the events and if it was ongoing.It was unknown who operated the devices and if operator was trained.The patient had used this device model for a unknown time, and the suspect device with (b)(4) (manufactured in jun2009) was used for an unknown time, and the suspect device with (b)(4) (manufactured in mar2013)was used for around six years; both were used longer than recommended use of 3 years.The devices were stopped being used and neither were returned to the manufacturer.The reporting consumer did not know if the event was related to 70% human insulin nph and 30% human insulin regular or the devices.Update 19aug2021: additional information received on 16aug2021 from the global product complaint database.Entered device specific safety summaries (dsss).Updated the medwatch fields/ european and canadian (eu/ca) device information, improper use and storage from no to yes and devices return status to not returned to manufacturer.Added date of manufacturer for (b)(4)/lot 1303d01 and (b)(4)/lot 0906d04 of humapen ergo ii devices.Corresponding fields and narrative updated accordingly.Update 26-aug-2021: information received from initial reporter on 20-aug-2021 did not include any new medically significant information as it was inconvenient to communicate at present.No changes were made to the case.

Manufacturer Narrative

Narrative field: new, updated, and corrected information is referenced within the update statements in describe event or problem.Please refer to update statement(s) dated (b)(6) 2021 in the describe event or problem field.No further follow-up is planned.This report is associated with 1819470-2021-00113 since there is more than one device implicated.Evaluation summary a male patient reported that the injection button of his humapen ergo ii device could not be pushed down in around (b)(6) 2021.The patient was hospitalized due to diabetes mellitus on an unspecified date around 2015.The device was not returned to the manufacturer for investigation (batch 0906d04, manufactured june 2009), as the timing of the reported ae did not correspond to the reported product complaint, and this was a well characterized issue.Malfunction unknown.A complaint history review 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 with high probability.While it is unknown how long the patient used the device, based on the amount of time elapsed since the device was manufactured (june 2009), it is likely the patient used it beyond its approved use life.The core instructions for use state the humapen ergo ii has been designed to be used for up to 3 years after first use.There is evidence of improper use.The patient likely used the device beyond its approved use life.It is unknown if this misuse is relevant to the pen jam issue or event of diabetes mellitus.

• 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: 12407588
• MDR Text Key: 280703813
• Report Number: 1819470-2021-00114
• 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: company representative,consum
• Type of Report: Initial
• Report Date: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS9557
• Device Lot Number: 0906D04
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 70 YR