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

Model Number MS9557

Device Problems Crack (1135); Fracture (1260)

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

Lilly case id: (b)(6).This report is associated with product complaint: (b)(4).This spontaneous case, reported by a consumer who contacted the company to report an adverse event, and product complaint (pc), concerned a (b)(6)-year-old (b)(6) male patient.Medical history was none.Concomitant medication included bailing capsule (as reported) for unknown indication.The patient received insulin lispro protamine suspension 75%/insulin lispro 25% treatment (rdna origin) injections (humalog mix25), from cartridge via a reusable device humapen ergo ii (blue), thrice daily (morning 10, noon 2, night 12), subcutaneously for the treatment of diabetes mellitus, beginning in 2010.In 2018, while taking insulin lispro protamine suspension 75%/insulin lispro 25% treatment, the screw thread of the clear cartridge holder near the rear end of a humapen ergo ii (blue) was cracked (lot number: 0912d02, pc number: (b)(4)).Reportedly, the issue could not be solved by phone, therefore the pen was processed based on procedure.On (b)(6) 2020, he was hospitalized due to regulating blood glucose (value, units and reference range were not provided).Further information regarding corrective treatment and outcome of the event was not provided.Status of insulin lispro protamine suspension 75%/insulin lispro 25% treatment was continued.The operator of humapen ergo ii (blue) and his/her training status was not provided.The general humapen ergo ii (blue) model duration was not provided but the suspect humapen ergo ii (blue) was started in 2010; approximately 10 years.The status of humapen ergo ii (blue) was unknown and its return status was not provided.The initial reporting consumer did not know if the event was related to insulin lispro protamine suspension 75%/insulin lispro 25% treatment and did not provide relatedness of event with humapen ergo ii (blue).Update 04-dec-2020: information received on 02-dec-2020 and 03-dec-2020 were processed at same time.Edit 08dec2020: 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(s) dated 21jan2021 in the b.5.Field.No further follow-up is planned.Evaluation summary : a male patient reported that the screw head of the cartridge holder of his humapen ergo ii device was cracked in 2018.He experienced abnormal blood glucose on (b)(6) 2020.The investigation of the returned device (batch 0912d02, manufactured december 2009) found the cartridge holder thread end was cracked, the pen housing was cracked near the bezel, the lens/bezel was cracked, and the soft touch was de-bonded and damaged.The damage to the cartridge holder rendered the device non-functional.Malfunction confirmed.However, testing of the device using a designated cartridge holder found the device met functional requirements.Evidence of an unknown chemical and use of excessive force was present where the soft touch was damaged.All internal components of the device were present and normal.The core instructions for use states if any of the parts of your humapen ergo ii appear broken or damaged, do not use.It further instructs the patient to not use the device if it appears broken or damaged and to contact lilly or their healthcare provider for a replacement pen.The patient used the device since 2010 (10 years ago).The user manual states the humapen ergo ii has been designed to be used for up to 3 years after first use.In addition, the patient continued to use the device after experiencing the complaint issue.The core instructions for use state if any of the parts of your humapen ergo ii appear broken or damaged, do not use.There is evidence of improper use.The damage to the cartridge holder, rendering the device non-functional, is consistent with damage while in the field.Additionally, the patient used the device beyond its approved use life and continued to use the device after experiencing the complaint issue.These misuses may be relevant to the event of abnormal blood glucose.

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 an adverse event and product complaint (pc), concerned a 52-year-old chinese han male patient.Medical history was none.Concomitant medication included bailing capsule (as reported) for unknown indication.The patient received insulin lispro protamine suspension 75%/insulin lispro 25% treatment (rdna origin) injections (humalog mix25), from cartridge via a reusable device humapen ergo ii (blue), thrice daily (morning 10, noon 2, night 12), subcutaneously for the treatment of diabetes mellitus, beginning in 2010.In 2018, while taking insulin lispro protamine suspension 75%/insulin lispro 25% treatment, the screw thread of the clear cartridge holder near the rear end of a humapen ergo ii (blue) was cracked (lot number: 0912d02, pc number: (b)(4)).Reportedly, the issue could not be solved by phone, therefore the pen was processed based on procedure.On (b)(6) 2020, he was hospitalized due to regulating blood glucose (value, units and reference range were not provided).The suspect device was used for approximately 10 years and continued to use the device after it was cracked.Further information regarding corrective treatment and outcome of the event was not provided.Status of insulin lispro protamine suspension 75%/insulin lispro 25% treatment was continued.The operator of humapen ergo ii (blue) and his/her training status was not provided.The general humapen ergo ii (blue) model duration was not provided but the suspect humapen ergo ii (blue) was started in 2010; approximately 10 years.The suspect device, which was manufactured in dec2009, was returned to the manufacturer on 03dec2020.The initial reporting consumer did not know if the event was related to insulin lispro protamine suspension 75%/insulin lispro 25% treatment and did not provide relatedness of event with humapen ergo ii (blue).Update 04-dec-2020: information received on 02-dec-2020 and 03-dec-2020 were processed at same time.Edit 08dec2020: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 21jan2021: additional information received on 21jan2021 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields/ european and canadian (eu/ca) device information, malfunction from unknown to yes/not cirm, and device return status to returned to manufacturer.Added date of manufacturer and date returned to manufacturer for the (b)(4) with associated lot 0912d02 of humapen ergo ii device.Upon internal review added device age of approximately 10 years.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: 10984826
• MDR Text Key: 222625377
• Report Number: 1819470-2020-00171
• 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: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS9557
• Device Lot Number: 0912D02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2020
• Date Manufacturer Received: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 52 YR
• Patient Weight: 81