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)

Patient Problem Headache (1880)

Event Type  Injury  

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This spontaneous case, reported by two consumers, who contacted the company to report adverse events and a product complaint (pc), concerned a 69-year-old male patient of unknown ethnicity.Medical history and concomitant medications were not provided.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) (humulin 70/30; 100 u/ml) injections, via a cartridge, through a reusable pen (humapen ergo ii), subcutaneously, for the treatment of diabetes beginning approximately in 1982.Dose and frequency were not provided.Since an unspecified date, while on human insulin isophane suspension 70%/human insulin 30% therapy, he did not see well and he had vision weakness.On an unknown date, he had an issue with his pen, when he pressed on the pen to take his dose, the pen was fixed and did not release the dose, but he did not know that there was no dose released; after that, he experienced a headache, so he decided to go to hospital, the headache lasted for five days before going to the hospital, it was unclear if patient was admitted.In hospital, the physician said that the pen did not release any doses and the pen had the full doses which meant that he lasted for five days without taking any insulin doses and he did not know (pc (b)(4) /lot number 1007d01); therefore, he started withdrawing medication from cartridge by syringe while he replaced the pen he had.There was a troubleshooting conducted and the pen worked well and released doses.He was not recovered from vision weakness.Information regarding corrective treatment, outcome of remaining events, hospitalization dates and additional details were not provided.Human insulin isophane suspension 70%/human insulin 30% therapy was on-going.The operator of the humapen ergo ii and their training status was not provided.The suspect humapen ergo ii general model duration of use was approximately 15 years.The suspect humapen ergo ii duration of use was not provided.The suspect humapen ergo ii did not return to manufacturer.The reporting consumer assessed the headache was related to the human insulin isophane suspension 70%/human insulin 30% therapy and did not provide a relatedness assessment between further events and the human insulin isophane suspension 70%/human insulin 30% therapy.The reporting consumer assessed the headache was also related to the humapen ergo ii and did not provide a relatedness assessment between further events and the humapen ergo ii.Update 26-oct-2022: information was received from affiliate on 19-oct-2022.Added suspect device, pc number as well as references in narrative.Narrative was updated accordingly with the new information.Update 31-oct-2022: information from the initial reporter was received on 31-oct-2022.Upon review, it was determined that the case (b)(4) is a duplicate of this case.Therefore the case (b)(4) should be deleted from the database.All the information of the case (b)(4) had been captured in case (b)(4).Edit 02-nov-2022: upon internal review of the initial information improper use or storage field for reusable pen was changed from no to yes.No further changes were performed.Update 14-nov-2022: additional information received on 08-nov-2022 from the global product complaint database.Entered the device specific safety summary (dsss), the medwatch and european and canadian (eu/ca) device fields, malfunction from unknown to no, and device return status to not returned to manufacturer; and added date of manufacture for the suspect humapen ergo ii device associated with pc (b)(4).Corresponding fields and narrative updated accordingly.

Manufacturer Narrative

Narrative field: new, updated, and corrected information is referenced within the update statements.Please refer to update statement(s) dated 14nov2022.No further follow-up is planned.Evaluation summary: a male patient reported that when he pressed on his humapen ergo ii to take his dose, the pen was fixed and did not release the dose, but he did not know that there was no dose released.The patient did not administer insulin for five days and experienced a headache.The device was not returned to the manufacturer for investigation (batch 1007d01, manufactured july 2010), but troubleshooting of the device was conducted, the pen worked well and released doses, and the issue was resolved.As the device was able to dispense insulin, the presence of a malfunction could not be confirmed.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 visual impairment.The core instructions for use state that the device is not recommended for the visually impaired.

• 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: 15812357
• MDR Text Key: 303816714
• Report Number: 1819470-2022-00083
• 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,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• 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: 1007D01
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2010
• 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: 69 YR
• Patient Sex: Male