MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN, UNKNOWN DEVICE; FOR TREATMENT PURPOSES

Model Number UNKNOWN

Device Problems Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)

Patient Problems Hyperglycemia (1905); Swelling (2091); Weight Changes (2607)

Event Type  Injury  

Manufacturer Narrative

No further follow-up is planned.Evaluation summary: a male patient reported that his humapen (unspecified device type) insulin leaked from the needle after injection.After injection, he would hold for a count of 20, but he did not keep pressing down the injection button.The patient experienced increased blood glucose.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 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 the injection pen needle every four or five days.The humapen core instructions for use states to use a new needle for each injection.The core instructions for use also states "you must push the injection button straight down for the dose to be delivered" and "continue to hold the button for 5 seconds, then remove the needle from your skin." there is evidence of improper use.The patient reused needles and does not continue to push the injection button down after injection for the hold count.These misuses may be relevant to the complaint and the event of increased blood glucose.

Event Description

Lilly case id: (b)(4).This report is associated with (b)(4).This solicited case, reported by a consumer via patient support program (psp), who contacted the company to report an adverse event and product complaint, concerned a (b)(6) old male patient of unknown ethnicity.Medical history included mother had diabetes and hospitalization.Concomitant medications insulin human and metformin for type 2 diabetes mellitus.The patient received insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) injections (humalog mix50) via cartridge via reusable device (humapen unknown device), twice a day (8iu each morning and 4iu each night), subcutaneously for the treatment of type 2 diabetes mellitus started on (b)(6) 2019.On an unspecified date, while on insulin lispro treatment, the weight lost much from (b)(6).On (b)(6) 2019 at 07:30 morning, the blood glucose tested was 8.75 and was very high.Approximately (b)(6) 2019, there was a lot of insulin lispro protamine suspension 50%/insulin lispro 50% leaked out from the needle of a humapen unknown device after the needle was removed.He injected 8 units of insulin lispro protamine suspension 50%/insulin lispro 50% and three drops of medicine would leak out, even the needle was removed after awaiting for a little longer.The insulin lispro protamine suspension 50%/insulin lispro 50% leaked out from the needle tip.The insulin lispro protamine suspension 50%/insulin lispro 50% cartridge was not broken.The injection process was slow.After injection, he would hold for counting 20 numbers, but he did not keep pressing down the injection button.As of (b)(6) 2019, after the needle was pulled out after the humapen unknown device.There was leakage of the needle which might cause the insulin not to be absorbed and not good to use ((b)(4), lot number: unknown).Reportedly, she changed the needle every four to five days (improper use of humapen unknown device).On an unknown date, he also experienced that injection site had a small lump.On an unknown date, in (b)(6) 2020, his insulin lispro protamine suspension 50%/insulin lispro 50% dose was adjusted to 10units in morning and 6units in evening due to unknown reason.On an unknown date, his blood glucose was not well controlled and the blood glucose was high (no values and reference ranges were provided).In (b)(6) 2020, he was hospitalized because the blood glucose was high.Information regarding corrective treatment and outcome of events were not provided.The status of insulin lispro protamine suspension 50%/insulin lispro 50% therapy was continued.The patient operator of the humapen unknown device and his training status were unknown.The humapen unknown device model duration of use was not provided.The suspect humapen unknown device duration of use was 76 days (from the date of the initial report) as it was started since (b)(6) 2019.It was unknown if the use of the suspect humapen unknown device was continued and was not returned to the manufacturer.The reporting consumer did not provide relatedness assessment of the events with insulin lispro protamine suspension 50%/insulin lispro 50% drug.The reporting consumer related the event of incorrect dose administered to humapen unknown device issue and did not provide a relatedness assessment for the remaining events to the humapen unknown device.Update 23-dec-2019: additional information received on 19-dec-2019 from the initial reporter via psp.Added a suspect device of humapen unknown.Updated the abbreviated to expanded narrative with new information.Update 31-dec-2019: information was received from rcp on 24-dec-2019, contain a product complaint number ((b)(4)).Pc was processed and no medically significant changes were made in the case.Update 25-jun-2020: additional information was received form initial reporter via psp on 23-jun-2020.Added a non serious event of injection site lump.Updated narrative with new information.Update 08-jul-2020: additional information was received from initial reporter via psp on 06-jul-2020.This case was upgrade to serious due to addition of serious event of high blood glucose.Added laboratory data and additional dosage regimen for insulin lispro protamine suspension 50%/insulin lispro 50% with updated dose and lot number.Updated action taken for suspect device age and eu/ca field was populated.Updated the narrative with new information.Upon review of the case, added non-serious event of incorrect dose administered, updated the improper use of humapen unknown device to yes and operator of the device to patient.Update 17jul2020: additional information received on 17jul2020 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields/ european and (b)(6) (eu/ (b)(6)) device information, and device return status to not returned to manufacturer for pc (b)(4) associated with unknown lot of humapen (unknown device).Corresponding fields and narrative updated accordingly.

• Brand Name: HUMAPEN, UNKNOWN DEVICE
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis, in
• Manufacturer Contact: chris davis ; lilly corporate center; indianapolis, in ; 4334585
• MDR Report Key: 10313962
• MDR Text Key: 204373060
• Report Number: 1819470-2020-00085
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial
• Report Date: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/06/2020
• Initial Date FDA Received: 07/23/2020
• 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: 60 YR
• Patient Weight: 65