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.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, concerns a (b)(6) female patient with ethnicity reported as (b)(6).Medical history of patient included appendicitis (had undergone surgery), insomnia, and right kidney atrophy with mild hydrops (as reported).Concomitant medications were not provided.The patient received insulin lispro regular 25% + insulin lispro nph 75% (rdna origin) (humalog 25) from cartridges, 10 units in the morning and 10 units in the evening, subcutaneously, for the treatment of diabetes mellitus, beginning on an unknown date around 2011.On an unknown exact date in 2012, approximately one after commencing insulin lispro regular 25% + insulin lispro nph 75%, patient had a hysterectomy, but further information was not provided.On an unknown exact date around 2014, insulin lispro regular 25% + insulin lispro nph 75% started to be delivered via humapen ergo ii lot number 1406d01.On (b)(6) 2021, approximately 7 years after starting to deliver though humapen ergo ii, the patient also had a thyroidectomy, but further information was not provided.On an unspecified date, insulin lispro regular 25% + insulin lispro nph 75% dose was changed by the patient herself to 8 units in the morning and 8 units in the evening and on an unspecified date, unknown if after changing insulin lispro regular 25% + insulin lispro nph 75% dose, the patient was hospitalized for treatment because of a little high blood glucose and left ear numbness (as reported).Information regarding hospitalization, laboratory exams and corrective treatment was not provided.It was unknown if patient recovered from the events and if she was discharged from the hospital.On an unspecified date in early(b)(6) 2021, unclear if after hospitalization, the threaded part of the cartridge holder of the humapen ergo ii which connected to the needle cracked (lot number 1406d01, (b)(4)).On an unknown date, she had cystitis and on (b)(6) 2021, she was hospitalized for treatment.Treatment and received and outcome was unknown for cystitis.As of (b)(6) 2021, insulin lispro regular 25% + insulin lispro nph 75% therapy was ongoing.It was unknown who operated the devices and if the operator was trained.The duration of use of humapen ergo ii device model was unknown, and of the reported device was approximately seven years.The device remained in use and its return was expected.The reporting consumer did not know if the events were related to insulin lispro regular 25% + insulin lispro nph whereas did not provide an opinion of relatedness with humapen ergo ii.Update 25-oct-2021: additional information received on 19-oct-2021 from complaint personnel was processed within initial case entry.Update 28-oct-2021: additional information received on 25-oct-2021 from initial consumer reporter.Added one serious event of cystitis.Updated case and narrative with new information.Edit 09nov2021: updated medwatch and european and (b)(6) (eu/(b)(6)) fields for expedited device reporting.No new information added.

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This spontaneous case, reported by a consumer, concerns a 59-year-old female patient with ethnicity reported as han.Medical history of patient included appendicitis (had undergone surgery), insomnia, and right kidney atrophy with mild hydrops (as reported).Concomitant medications were not provided.The patient received insulin lispro regular 25% + insulin lispro nph 75% (rdna origin) (humalog 25) from cartridges, 10 units in the morning and 10 units in the evening, subcutaneously, for the treatment of diabetes mellitus, beginning on an unknown date around 2011.On an unknown exact date in 2012, approximately one after commencing insulin lispro regular 25% + insulin lispro nph 75%, patient had a hysterectomy, but further information was not provided.On an unknown exact date around 2014, insulin lispro regular 25% + insulin lispro nph 75% started to be delivered via humapen ergo ii lot number 1406d01.On 01-may-2021, approximately 7 years after starting to deliver though humapen ergo ii, the patient also had a thyroidectomy, but further information was not provided.On an unspecified date, insulin lispro regular 25% + insulin lispro nph 75% dose was changed by the patient herself to 8 units in the morning and 8 units in the evening and on an unspecified date, unknown if after changing insulin lispro regular 25% + insulin lispro nph 75% dose, the patient was hospitalized for treatment because of a little high blood glucose and left ear numbness (as reported).Information regarding hospitalization, laboratory exams and corrective treatment was not provided.It was unknown if patient recovered from the events and if she was discharged from the hospital.On an unspecified date in early oct-2021, unclear if after hospitalization, the threaded part of the cartridge holder of the humapen ergo ii which connected to the needle cracked (lot number 1406d01, pc number (b)(4)).On an unknown date, she had cystitis and on 20-oct-2021, she was hospitalized for treatment.Treatment and received and outcome was unknown for cystitis.As of 28-oct-2021, insulin lispro regular 25% + insulin lispro nph 75% therapy was ongoing.It was unknown who operated the devices and if the operator was trained.The duration of use of humapen ergo ii device model was approximately seven years reported as used the device since 2014.The suspect humapen ergoii associated with product complaint (b)(4) was returned to the manufacturer on 01nov2021.The reporting consumer did not know if the events were related to insulin lispro regular 25% + insulin lispro nph whereas did not provide an opinion of relatedness with humapen ergo ii.Update 25-oct-2021: additional information received on 19-oct-2021 from complaint personnel was processed within initial case entry.Update 28-oct-2021: additional information received on 25-oct-2021 from initial consumer reporter.Added one serious event of cystitis.Updated case and narrative with new information.Edit 09nov2021: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 30nov2021: additional information received on 29nov2021 from the global product complaint database.Entered device specific safety summary (dsss) for humapen ergo ii device associated with pc (b)(4), lot 1406d01.Updated the medwatch fields/ european and canadian (eu/ca) device information, malfunction from unknown to no, and device return status to returned to manufacturer.Added date of manufacturer and date returned to manufacturer for the device.The device age was updated.Corresponding fields and narrative updated 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(s) dated 01dec2021 in the b.5.Field.No further follow- up is planned.Evaluation summary a female patient reported that the cartridge holder of her humapen ergo ii was cracked at the threaded part which connected to the needle.She experienced increased blood glucose.The investigation of the returned device (batch 1406d01, manufactured june 2014) found the device met functional requirements and met dose accuracy and glide (injection) force specifications.No malfunction was identified.The investigation also found the cartridge holder needle thread end was cracked due to excessive force.However, this issue did not cause a malfunction.The patient reportedly used the device since 2014, approximately seven years.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 used the device beyond the recommended use period this misuse may not be relevant to the complaint or the event of increased blood glucose, as the returned device met performance specifications.

• Brand Name: HUMAPEN ERGO II
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• Manufacturer (Section G): TECH GROUP NORTH AMERICA INC. DBA WEST; 640 south rockford drive; tempe AZ 85281
• Manufacturer Contact: chris davis ; lilly corporate center; indianapolis, IN 46285 ; 3174334585
• MDR Report Key: 12815534
• MDR Text Key: 282986221
• Report Number: 1819470-2021-00153
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K151686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/28/2021

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: Other
• Device Model Number: MS9557
• Device Lot Number: 1406D01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2021
• Initial Date Manufacturer Received: 10/19/2021
• Initial Date FDA Received: 11/15/2021
• Supplement Dates Manufacturer Received: 11/29/2021
• Supplement Dates FDA Received: 12/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2014
• 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
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 55 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian