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

Model Number MS9557

Device Problems Mechanical Jam (2983); Insufficient Information (3190)

Patient Problem Hyperglycemia (1905)

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, who contacted the company to report adverse events and a product complaint, concerned an 80- years male patient of han nationality.Medical history included kidney disease and rectal cancer.The concomitant medications included a lot of medicines in aspects of myocardial infarction, cerebral infarction, rectal cancer (name unspecified).The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) from a cartridge, 22 units in morning and 18 units in evening, administered subcutaneously, for the treatment of type 2 diabetes mellitus, beginning on an unknown date in 2003, via a reusable pen humapen ergo ii, beginning on (b)(6) 2013.On unspecified date, possibly after starting human insulin isophane suspension 70%/human insulin 30%, he experienced myocardial infarction and cerebral infarction (more information could not be obtained).Since an unknown date, after starting human insulin isophane suspension 70%/human insulin 30%, he was hospitalized several times, due to diabetes, kidney disease and swollen feet.It was reported he developed cerebral thrombosis, after starting human insulin isophane suspension 70%/human insulin 30%.On (b)(6) 2023, due to malfunctioning of injection pen, he did not inject insulin (lot.No.1201d04, pc.No.(b)(4) and as of (b)(6) 2023, the fasting blood glucose was 16 (units, date and reference range not provided).It was reported, during human insulin isophane suspension 70%/human insulin 30% therapy, his height slowly changed from 169 cm to 167 cm due to old age.The events; myocardial infarction, cerebral infarction and cerebral thrombosis were considered serious by the company due to medical significance.Information regarding corrective treatment and hospitalization details was unknown.Outcome of missed dose was not recovered and outcome of remaining events were unknown.Status of human insulin isophane suspension 70%/human insulin 30% therapy was discontinued.Follow-up was not possible as reporter refused to be contacted via phone.The operator of device was unknown and his/her training status was not provided.The general and suspect humapen ergo ii model duration of use was ten years as it was started on (b)(6) 2013.The action taken with suspect humapen was unknown and was available for return.The reporting consumer did not know if the events were related with human insulin isophane suspension 70%/human insulin 30% and did not provide relatedness of events with humapen ergo ii.

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.

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 28aug2023 in the b.5.Field.No further follow-up is planned.Evaluation summary: a patient and his family members reported that the injection button of the patient's humapen ergo ii device could be pressed down but the injection screw did not move.He was unable to inject his insulin.The patient experienced inadequate control of diabetes mellitus.The device was not returned to the manufacturer for investigation (batch 1201d04, manufactured january 2012).Malfunction unknown.A complaint history review did not identify any atypical findings with regard to pen jammed and injection screw/ratchet not moving issues.All humapen ergo ii 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 reported changing needles every 3 to 4 days.The core instructions for use state to use a new needle for each injection.The patient reported that the device had been used since 2013.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 reused needles and used the device beyond its approved use life.Needle reuse may be relevant to the complaint of pen jamming and injection screw not moving.It is unknown if these misuses are relevant to the event of inadequate control of diabetes mellitus.

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 adverse events and a product complaint, concerned an 80- years male patient of han nationality.Medical history included kidney disease and rectal cancer.The concomitant medications included a lot of medicines in aspects of myocardial infarction, cerebral infarction, rectal cancer (name unspecified).The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) from a cartridge, 22 units in morning and 18 units in evening, administered subcutaneously, for the treatment of type 2 diabetes mellitus, beginning on an unknown date in 2003, via a reusable pen humapen ergo ii, beginning on (b)(6) 2013.On unspecified date, possibly after starting human insulin isophane suspension 70%/human insulin 30%, he experienced myocardial infarction and cerebral infarction (more information could not be obtained).Since an unknown date, after starting human insulin isophane suspension 70%/human insulin 30%, he was hospitalized several times, due to diabetes, kidney disease and swollen feet.It was reported he developed cerebral thrombosis, after starting human insulin isophane suspension 70%/human insulin 30%.On (b)(6) 2023, due to malfunctioning of injection pen, he did not inject insulin (lot.No.1201d04, pc.No.(b)(4) and as of (b)(6) 2023, the fasting blood glucose was 16 (units, date and reference range not provided).Also, it was reported that the patient reused needles and stated that the device had been used since 2013 (improper use).It was reported, during human insulin isophane suspension 70%/human insulin 30% therapy, his height slowly changed from 169 cm to 167 cm due to old age.The events; myocardial infarction, cerebral infarction and cerebral thrombosis were considered serious by the company due to medical significance.Information regarding corrective treatment and hospitalization details was unknown.Outcome of missed dose was not recovered and outcome of remaining events were unknown.Status of human insulin isophane suspension 70%/human insulin 30% therapy was discontinued.Follow-up was not possible as reporter refused to be contacted via phone.The operator of device was unknown and his/her training status was not provided.The general and suspect humapen ergo ii model duration of use was ten years as it was started on (b)(6) 2013.The action taken with suspect humapen was unknown and was not returned yo the manufacturer for investigation.The reporting consumer did not know if the events were related with human insulin isophane suspension 70%/human insulin 30% and did not provide relatedness of events with humapen ergo ii.Update 28aug2023: additional information received on 21aug2023 from the global product complaint database.Entered device specific safety summary (dsss) for humapen ergo ii device associated with pc (b)(4), lot 1201d04.Updated the medwatch fields/ european and canadian (eu/ca) device information and device return status to not returned to manufacturer.Added date of manufacturer for the device and improper use or storage was updated from no to yes 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
• Manufacturer (Section G): TECH GROUP NORTH AMERICA INC. DBA WEST; 640 south rockford drive; tempe AZ 85281
• Manufacturer Contact: catherine cassidy ; lilly corporate center; indianapolis, IN 46285
• MDR Report Key: 17637706
• MDR Text Key: 322147060
• Report Number: 1819470-2023-00054
• 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: 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MS9557
• Device Lot Number: 1201D04
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2012
• 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: 80 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian