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

Model Number MS9557

Device Problems Failure to Deliver (2338); Mechanical Jam (2983); Physical Resistance/Sticking (4012)

Patient Problems Hyperglycemia (1905); Diabetic Ketoacidosis (2364); Coma (2417)

Event Date 08/20/2021

Event Type  Injury  

Event Description

(b)(4).This solicited case, reported by a consumer via a patient support program (psp) concerned a (b)(6) male patient of unspecified origin.Medical history and concomitant medications were not provided.The patient received insulin lispro (rdna origin) injections (humalog 100 u/ml) via a reusable pen (humapen ergo ii) subcutaneously.Dosage regimen, indication for use and start date were not provided.On (b)(6) 2021, while attempting to inject his insulin lispro dose the screw of the humapen ergo ii got stuck and the pen did not release the insulin (product complaint, (b)(4); lot: unknown).Due to the issue, he was taken to a hospital where he was informed that he went into a hyperglycemic coma and had high acetone blood level (no values, units or reference ranges provided); however, it was not informed if he was hospitalized.He then started taking his insulin through insulin syringes.Information regarding corrective treatments or outcome of the events was not provided.Insulin lispro treatment was continued.The operator of the humapen ergo ii was the caregiver of the patient and his/her training status was not provided.The general humapen ergo ii duration of use was not provided.The suspect reported humapen ergo ii duration of use was around four months.The suspect reported humapen ergo ii was kept in use and it was unknown if it would be returned.The reporting consumer did not provide a relatedness assessment between the events and insulin lispro treatment but related the events to the humapen ergo ii.Edit 07oct2021: updated medwatch and european and (b)(6) (eu/(b)(6)) fields for expedited device reporting.No new information added.Edit 11-oct-2021: upon information received from the responsible complaint personnel (rcp), a pc number was received for the information from 20-sep-2021, accepted accordingly and included in narrative.No additional changes were done to the case.Update 13-oct-2021: information received on 06-oct-2021 from the initial reporter did not include new medically significant information.No changes were made to the case.Edit 14oct2021: updated medwatch and european and (b)(6) (eu/(b)(6)) 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 (s) dated 15nov2021 in the b.5.Field.No further follow-up is planned.Evaluation summary: a report was received on behalf of a male patient that the patient's humapen ergo ii device "got stuck and the pen did not release the insulin".The patient experienced diabetic hyperglycaemic coma and increased blood ketone body.The device was not returned to the manufacturer for investigation (batch number unknown).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.All humapen ergo ii devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality with high probability.The patient reported that the needle was not changed for each injection.The core instructions for use state to use a new needle for each injection.There is evidence of improper use.The patient reused needles.This misuse may be relevant to the complaint and the events of diabetic hyperglycaemic coma and increased blood ketone body.

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 6-year-old male patient of unspecified origin.Medical history and concomitant medications were not provided.The patient received insulin lispro (rdna origin) injections (humalog 100 u/ml) via a reusable pen (humapen ergo ii) subcutaneously.Dosage regimen, indication for use and start date were not provided.On (b)(6) 2021, while attempting to inject his insulin lispro dose the screw of the humapen ergo ii got stuck and the pen did not release the insulin and she did not administer her dose (product complaint, (b)(4); lot: unknown).Due to the issue, he was taken to a hospital where he was informed that he went into a hyperglycemic coma and had high acetone blood level (no values, units or reference ranges provided), was hospitalized and the doctor injected him with the insulin using a syringe.On an unspecified date, he was discharged.The event of increased acetone levels was considered life-threatening by the reporter.As corrective treatment, the doctor injected him with an unspecified insulin.On unspecified dates, the use of a single needle was done, for all the day (improper use).He then started taking his insulin through insulin syringes.Information regarding corrective treatments or outcome of the events was not provided.Insulin lispro treatment was continued.The operator of the humapen ergo ii was the mother of the patient and she had been trained by the doctor.The general humapen ergo ii duration of use was not provided.The suspect reported humapen ergo ii duration of use use was less than two years, it was started approximately in 2020.The action taken with suspect humapen ergo ii was not reported.The device was not returned to the manufacturer and its return was not expected.The reporting consumer did not relate the events to the insulin lispro treatment but related them the humapen ergo ii.Edit 07oct2021: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Edit 11-oct-2021: upon information received from the responsible complaint personnel (rcp), a pc number was received for the information from 20-sep-2021, accepted accordingly and included in narrative.No additional changes were done to the case.Update 13-oct-2021: information received on 06-oct-2021 from the initial reporter did not include new medically significant information.No changes were made to the case.Edit 14oct2021: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 25-oct-2021: additional information was received on 20-oct-2021, via psp in response to the medical questions.Added: the hospitalization details for the event of hyperglycemic coma.Updated: the relatedness assessment for the events to no from not reported, the event of hyperglycemic coma to serious due to hospitalization and high acetone levels to life-threatening, the corrective treatment to yes from unknown, for the event of hyperglycemic coma, the device fields for improper use, operator of device, her training status and availability of device for further evaluation for the suspect humapen.Updated the narrative accordingly.Update 27oct2021: additional information received on 22oct2021 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields/ european and canadian (eu/ca) device information for (b)(4) associated with unknown lot of humapen ergo ii device.Corresponding fields and narrative updated accordingly.Update 15nov2021: additional information received on 09nov2021 from the global product complaint database.Updated device specific safety summary (dsss).

• 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): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• Manufacturer Contact: chris davis ; lilly corporate center; indianapolis, IN 46285
• MDR Report Key: 12632927
• MDR Text Key: 281990291
• Report Number: 1819470-2021-00136
• 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: 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS9557
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/20/2021
• 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): Other; Hospitalization; Life Threatening
• Patient Age: 6 YR
• Patient Sex: Male