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

Model Number MS9557

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Hemorrhage/Bleeding (1888); Swelling (2091)

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

Lilly case id: (b)(4).This report is associated with product compliant: (b)(4).This solicited case, reported by consumer via a patient support program (psp), concerned a (b)(6) (at the time of initial report) chinese han female patient.Medical history included hyperglycemia, hypertension, hyperlipidemia, rheumatoid and congenital tremor.Her father and mother had hypertension.Concomitant medications included acarbose for diabetes mellitus.The patient received insulin lispro (rdna origin) injections (humalog, 100u/ml), from an unknown formulation via a reusable pen humapen ergo ii (blue), twice daily (19 units in morning and evening) subcutaneously for the treatment of diabetes mellitus, beginning on (b)(6) 2018.She did not change her needle before each injection and exhaust was not done before injection.On an unknown date, while on insulin lispro therapy, she had problem with her humapen ergo ii (blue).She thought it was the problem with the spring of humapen ergo ii (blue) due to which the insulin could not be fully injected during injection (batch number: unknown and product complaint number: (b)(4)).So, the control of blood glucose was not good (value, unit and reference range not provided), eyes could not see, fundus hemorrhage and leg swelling occurred, and she was hospitalized.She thought it was the problem with the spring of humapen ergo ii (blue).She wanted a new injection pen.On an unknown date, she was recovering from blood glucose abnormal and eyes could not see.Information regarding further hospitalization details, corrective treatment and outcome of remaining events was not provided.Treatment with insulin lispro was continued.The patient was the operator of humapen ergo ii (blue) and her training status was not provided.The general humapen ergo ii (blue) model duration of use was not provided.The suspect humapen ergo ii (blue) duration of use was approximately 13 months as it was started on (b)(6) 2018.The status of humapen ergo ii (blue) was discontinued and its return was expected.The initial reporting consumer did not provide the relatedness assessment of the events with insulin lispro therapy.The initial reporting consumer considered that the events were related to humapen ergo ii (blue) issue.Update (b)(6) 2019: initial and follow up information received on 18-sep-2019 was processed at same time.Edit (b)(6) 2019: upon review of the initial information received on 18-sep-2019, corrected start date of insulin lispro in narrative (from (b)(6) 2019 to (b)(6) 2018).No other changes were made to the case.Update (b)(6) 2019: correction of initial information received on 18-sep-2019 was received from the affiliate.Start date of insulin lispro and device had been already amended (from (b)(6) 2019 to (b)(6) 2018).Upon review of initial information, updated description as reported of the accidental underdose event (replaced malfunction with issue), updated case accordingly.Complaint reference number was processed.Update (b)(6) 2019: information received from the affiliate on 26-sep-2019.Added pc number to the case (already processed in the case).No other changes were made to the case.Edit (b)(6) 2019: updated medwatch 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 09oct2019 in the b.5.Field.No further follow-up is planned.Evaluation summary: a female patient reported a malfunction of her humapen ergo ii device.She stated the insulin could not be completely injected during the injection.The patient experienced abnormal blood glucose.The device was not returned to the manufacturer for investigation (batch number unknown).The device was checked by a diabetes educator; the issue was solved, and the pen was working normally.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 core user manual instructs the patient to prime the device using 2 units before every injection until insulin is seen at the needle tip and to use a new needle for each injection.There is evidence of improper use.The patient reused needles and did not prime the device before each injection.This may be relevant to the complaint that the insulin could not be completely injected and the event of abnormal blood glucose.

Event Description

Lilly case id: (b)(4).This solicited case, reported by consumer via a patient support program (psp), concerned a 72-year-old (at the time of initial report) chinese han female patient.Medical history included hyperglycemia, hypertension, hyperlipidemia, rheumatoid and congenital tremor.Her father and mother had hypertension.Concomitant medications included acarbose for diabetes mellitus.The patient received insulin lispro (rdna origin) injections (humalog, 100u/ml), from an unknown formulation via a reusable pen humapen ergo ii (blue), twice daily (19 units in morning and evening) subcutaneously for the treatment of diabetes mellitus, beginning on (b)(6) 2018.She did not change her needle before each injection and exhaust was not done before injection.On an unknown date, while on insulin lispro therapy, she had problem with her humapen ergo ii (blue).She thought it was the problem with the spring of humapen ergo ii (blue) due to which the insulin could not be fully injected during injection (batch number: unknown and product complaint number: 4885340).So, the control of blood glucose was not good (value, unit and reference range not provided), eyes could not see, fundus hemorrhage and leg swelling occurred, and she was hospitalized.She thought it was the problem with the spring of humapen ergo ii (blue).She wanted a new injection pen.On an unknown date, she was recovering from blood glucose abnormal and eyes could not see.Information regarding further hospitalization details, corrective treatment and outcome of remaining events was not provided.Treatment with insulin lispro was continued.The patient was the operator of humapen ergo ii (blue) and her training status was not provided.The general humapen ergo ii (blue) model duration of use was not provided.The suspect humapen ergo ii (blue) duration of use was approximately 13 months as it was started on (b)(6) 2018.The suspect device was not returned to the manufacturer as it was noted by the diabetic educator that the operational issue was solved.The initial reporting consumer did not provide the relatedness assessment of the events with insulin lispro therapy.The initial reporting consumer considered that the events were related to humapen ergo ii (blue) issue.Update 24-sep-2019: initial and follow up information received on 18-sep-2019 was processed at same time.Edit 26-sep-2019: upon review of the initial information received on 18-sep-2019, corrected start date of insulin lispro in narrative (from (b)(6) 2019 to (b)(6) 2018).No other changes were made to the case.Update 26-sep-2019: correction of initial information received on 18-sep-2019 was received from the affiliate.Start date of insulin lispro and device had been already amended (from (b)(6) 2019 to (b)(6) 2018).Upon review of initial information, updated description as reported of the accidental underdose event (replaced malfunction with issue), updated case accordingly.Complaint reference number was processed.Update 01-oct-2019: information received from the affiliate on 26-sep-2019.Added pc number to the case (already processed in the case).No other changes were made to the case.Edit 02oct2019: updated medwatch fields for expedited device reporting.No new information added.Update 09oct2019: additional information received on 09oct2019 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 no, and device return status to not returned to manufacturer for (b)(4) associated with unknown lot of humapen ergo ii 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
• MDR Report Key: 9158483
• MDR Text Key: 167412279
• Report Number: 1819470-2019-00184
• 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,Followup
• Report Date: 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MS9557
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 72 YR
• Patient Weight: 47