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

Model Number MS9557

Device Problems Mechanical Problem (1384); Failure to Deliver (2338); Insufficient Information (3190)

Patient Problems Diabetic Ketoacidosis (2364); Cramp(s) /Muscle Spasm(s) (4521)

Event Type  Injury  

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned a 49-year-old (at the time of initial report) female patient of unknown origin.Medical history and concomitant medication were not provided.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injection (humulin 70/30, 100u/ml) from unknown formulation via reusable pen humapen ergo ii, 40 units in morning and 10 units at night, subcutaneously, for the treatment of diabetes mellitus, beginning on an unknown date.On an unknown date in (b)(6) 2023, while on human insulin isophane suspension 70%/human insulin 30% therapy, her humapen ergo ii did not release insulin due to defect in pen due to which she missed doses for several days and she did not know that the pen was not releasing the insulin ((b)(4); lot 2010d02), which led to elevation in blood glucose level, reached up to 600mg/dl (reference range was not provided), which led to diabetic ketoacidosis and spasms all over the body.Approximately on (b)(6) 2023, she was hospitalized due to the events of blood sugar increased, diabetic ketoacidosis and spasms.She was hospitalized for five days and she left the hospital on (b)(6) 2023.On an unknown date while in hospital she had discontinued the human insulin isophane suspension 70%/human insulin 30% therapy as per the physician.She changed the needle every two days of using and stored the device in the refrigerator (improper use).Information regarding corrective treatment was not provided.She was recovering from diabetic ketoacidosis, while the outcome of remaining events were recovered.Status of restarting the human insulin isophane suspension 70%/human insulin 30% therapy was not provided.The operator of the humapen ergo ii was the patient and her training status was unknown.The device model duration of use and the suspect device duration of use were not reported.The action taken with the suspect device was not provided and its return status not expected.The initial reporting consumer did not relate the events with the human insulin isophane suspension 70%/human insulin 30% therapy while related the events with the humapen.Edit 24-may-2023: upon review of the information received on 10-may-2023, updated improper use or storage from no to yes for suspect device and in narrative; updated pc and lot information in narrative and added eu/ca fields for the device.No other changes were made to the case.Edit 24may2023: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.

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 04jul2023 in the b.5.Field.No further follow-up is planned.Evaluation summary: the daughter of a female patient reported that the patient's humapen ergo ii device "did not release insulin due to defect in pen due to which she missed doses for several days and she did not know that the pen was not releasing the insulin." there was no further information about the exact alleged defect of the pen.The patient experienced diabetic ketoacidosis and muscle spasms.The device was not returned to the manufacturer for investigation (batch: 2010d02, manufactured october 2020).Malfunction unknown.A batch record review and safety case review of the batch did not identify any atypical findings.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 two days and storing the device in the refrigerator.The core instructions for use state to use a new needle for each injection, to remove the needle after every use, to not store the pen with the needle attached, and to not to store the device in a refrigerator.There is evidence of improper use.The patient reused needles and stored the device in the refrigerator.These misuses may be relevant to the complaint that the device did not release insulin and the event of diabetic ketoacidosis.

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned a 49-year-old (at the time of initial report) female patient of unknown origin.Medical history and concomitant medication were not provided.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injection (humulin 70/30, 100u/ml) from unknown formulation via reusable pen humapen ergo ii, 40 units in morning and 10 units at night, subcutaneously, for the treatment of diabetes mellitus, beginning on an unknown date.On an unknown date on (b)(6) 2023, while on human insulin isophane suspension 70%/human insulin 30% therapy, her humapen ergo ii did not release insulin due to defect in pen due to which she missed doses for several days and she did not know that the pen was not releasing the insulin (b)(4); lot: 2010d02), which led to elevation in blood glucose level, reached up to 600mg/dl (reference range was not provided), which led to diabetic ketoacidosis and spasms all over the body.Approximately on (b)(6) 2023, she was hospitalized due to the events of blood sugar increased, diabetic ketoacidosis and spasms.She was hospitalized for five days and she left the hospital on (b)(6) 2023.On an unknown date while in hospital she had discontinued the human insulin isophane suspension 70%/human insulin 30% therapy as per the physician.She changed the needle every two days of using and stored the device in the refrigerator (improper use).Information regarding corrective treatment was not provided.She was recovering from diabetic ketoacidosis, while the outcome of remaining events were recovered.Status of restarting the human insulin isophane suspension 70%/human insulin 30% therapy was not provided.The operator of the humapen ergo ii was the patient and her training status was unknown.The device model duration of use and the suspect device duration of use were not reported.The action taken with the suspect device was not provided and was not returned to the manufacturer for investigation.The initial reporting consumer did not relate the events with the human insulin isophane suspension 70%/human insulin 30% therapy while related the events with the humapen.Edit 24-may-2023: upon review of the information received on 10-may-2023, updated improper use or storage from no to yes for suspect device and in narrative; updated pc and lot information in narrative and added eu/ca fields for the device.No other changes were made to the case.Edit 24may2023: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 04jul2023: additional information received on 28jun2023 from the global product complaint database.Entered device specific safety summary (dsss) for humapen ergo ii device associated with (b)(4), lot number: 2010d02.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.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: chris davis ; lilly corporate center; indianapolis ; 3174332191
• MDR Report Key: 16995478
• MDR Text Key: 315872076
• Report Number: 1819470-2023-00040
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: K151686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• 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: 2010D02
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 49 YR
• Patient Sex: Female