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

Model Number UNKNOWN

Device Problem Leak/Splash (1354)

Patient Problems Bruise/Contusion (1754); Hemorrhage/Bleeding (1888); Hyperglycemia (1905); Hypoglycemia (1912); Pain (1994); Scarring (2061); Swelling (2091); Weakness (2145); Discomfort (2330); Sleep Dysfunction (2517)

Event Type  Injury  

Manufacturer Narrative

New, updated and corrected information is referenced within the update statements.Please refer to update statement(s) dated 06aug2020.No further follow-up is planned.Evaluation summary: a female patient reported that, when using her humapen (unspecified device type), seven to eight drops of insulin leaked from the needle even after holding the injection button down for 30 seconds after injection.She experienced abnormal 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.There is no evidence of improper use or storage.

Event Description

(b)(4).This solicited case reported by a consumer via patient support program (psp) concerned a (b)(6)-years-old female patient of (b)(6) origin.Medical history included fatty liver, was hospitalized for unknown indication, abnormal liver function, had penicillin allergy and mother had diabetes.Concomitant medications were not provided.The patient received human insulin (rdna origin) injection (humulin r, 100u/ml) from a cartridge formulation, via reusable humapen unknown device, 5 units each morning and 7 units each night, subcutaneously, for the treatment of diabetes mellitus, beginning on an unknown date in 2012.Received insulin lispro (rdna origin) injection (humalog, 100u/ml) from a cartridge formulation via reusable humapen unknown device, 7 units each morning and 8 units each night for the treatment of diabetes beginning on an unknown date from (b)(6) 2017.On (b)(6) 2019, fasting blood glucose and postprandial blood glucose were high (values, units and reference ranges were not provided).Since an unknown date blood glucose was not very normal and it was high.The blood sugar value was fasting 12, more than 10, postprandial was more than 16, 17and 19.Since an unknown date there was little (scar) bleeding, becoming cyan and purple, having eczema in injection site after finishing injection.Since an unknown date blood glucose was suddenly high and suddenly low sometimes it was high, sometimes it was very low.When it was high, it was more than 16, and when it was low, it was more than 6 (units and reference ranges were not provided).On an unknown date in 2017, she had a situation of poor sleep.So doctor changed it to insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) injection (humalog mix 25, 100u/ml) from a cartridge formulation, via reusable humapen unknown device, 7 units each morning, 8 units each night subcutaneously, for the treatment of type ii diabetes mellitus, beginning on an unknown date in (b)(6) 2018(conflicting data also reported as 2017 and 2012).As of (b)(6) 2020, the dose of insulin lispro protamine suspension 75%/insulin lispro 25% was 15 units in the morning, 16 units in the evening.On (b)(6) 2019, her blood glucose was high and fasting blood glucose was also high.Since an unknown date the blood sugar was not very normal, and the blood sugar value was high.On an unknown date in (b)(6) 2019, she was hospitalized for cold, abnormal blood sugar discomfort and no strength.Her glycosylated hemoglobin was high (7.8) (units and reference ranges were not provided).On an unknown date situation of discomfort had improved, situation of poor sleep was not recovering every time he caught a cold, the blood sugar would be abnormal, and the person would be uncomfortable and was no strength.As of (b)(6) 2020, after using insulin lispro there would still be high blood sugar.The fasting blood sugar value was 7-8, and the postprandial blood sugar value was 11-13.She was in the hospital (outpatient or inpatient was not provided), and mentioned the laboratory test report (what kind of inspection was not provided).On an unspecified date she discontinued the use of insulin lispro protamine suspension 75%/insulin lispro 25% due to unspecified reasons and started using insulin aspart 30.On an unspecified date in 2019, she discontinued the use of insulin aspart and re-started the use of insulin lispro protamine suspension 75%/insulin lispro 25%, subcutaneously, for the treatment of type ii diabetes mellitus.On an unspecified date, while on therapy with insulin lispro protamine suspension 75%/insulin lispro 25% she had hypoglycemia with the blood glucose value of 1.6, but there was no problem with her body.On another unspecified date while on insulin lispro protamine suspension 75%/insulin lispro 25%, her blood glucose was suddenly high and suddenly low.On an unknown date while on therapy with insulin lispro protamine suspension 75%/insulin lispro 25% her belly was bruised, swollen and pained.As of (b)(6) 2020, she had the situation of belly (injection site) pain occurred after injected insulin lispro.On a date unspecified, she indicated the liquid medicine dropped out (seven- eight drops) after injected by insulin injection pen and pulled out the needle (possible incorrect dose) ((b)(4), lot unknown).Information regarding corrective treatment and outcome of the events of hypoglycemia, blood glucose fluctuation, injection site bruising, pain and swelling on the belly was not provided.Information regarding further corrective treatment, outcome of the remaining events and status of insulin lispro protamine suspension 75%/insulin lispro 25% was ongoing.Insulin lispro status was unknown and it was unknown if human insulin was restarted.The patient was the operator of the reusable humapen unknown device and her training status was not provided.The general reusable humapen unknown device model duration of use and suspect reusable humapen unknown device duration of use was unknown.The status of suspect reusable humapen unknown device was unknown and was not returned to manufacturer.The initial reporting consumer did not relate non serious event of blood glucose increased and decreased to insulin lispro protamine suspension 75%/insulin lispro 25% was and did not provided relatedness between the remaining events and human insulin, insulin lispro protamine suspension 75%/insulin lispro 25% and insulin lispro.Event of poor sleep and blood glucose decreased, serious event of cold, discomfort, weakness and blood glucose abnormal was not associated with human insulin.The initial reporting consumer did not provide the relatedness assessment for the events of hypoglycemia, blood glucose fluctuation,injection site bruising, pain and swelling on the belly to the therapy with insulin lispro protamine suspension 75%/insulin lispro 25% and believed that the events of bruising, pain and swelling on the belly were caused by the needle being soft, one big, one small and not standard.The initial reporting consumer did not provide relatedness assessment between the events and humapen unknown device but associated the event of incorrect dose administered to the product complaint of humapen unknown device.Edit 29-oct-2019: upon review of the information received on 15-oct-2019, the listedness and as determined causality of the events injection site hemorrhage and injection site discoloration were updated for the insulin lispro (rdna origin) and insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) drug.No other changes were made to the case.Updated the narrative accordingly.Update 31-dec-2019: additional information was received from the initial reporting consumer on 25-dec-2019 via patient support program (psp).Added lab data and dosage regimen for insulin lispro protamine suspension 75%/insulin lispro 25% as well as one new non-serious event of blood glucose decreased.Updated event description for blood glucose increased.Updated narrative with the new information.Update 20-mar-2020: case was initially non serious.Additional information was received from initial reporter via psp on 11-mar-2020.Added medical history, dosage regimen of human insulin, insulin lispro protamine suspension 75%/insulin lispro 25% conflicting start date was added for both these drug.Added serious event of blood glucose abnormal, asthenia, discomfort, and cold, and non serious event of cold asthenia, glycosylated hemoglobin increased(lab data) and discomfort.Updated narrative with new information.Update 06-apr-2020: additional information was received from the initial reporting consumer on 02-apr-2020 via psp.Added two lab test of blood glucose.Updated description as reported for the event of blood glucose increased.Updated narrative with new information.Update 15-jul-2020: additional information was received from the initial reporting consumer via psp, on 15-jul-2020.Added three lab tests, two dosage regimen and updated the indication for use of the insulin lispro protamine suspension 75%/insulin lispro 25% therapy.Also, added five new non-serious events of hypoglycemia, blood glucose fluctuation, injection site bruising, pain and swelling on the belly to the case.Updated the narrative accordingly.Update 30-jul-2020: additional information was received from the initial reporting consumer on 27-jul-2020 via psp.Added one non-serious event of incorrect dose administered.Added one suspect humapen unknown device.Updated description as reported for the event of injection site pain.Updated formulation from unknown to cartridge for insulin lispro mix 25 and human insulin.Updated causality statement and narrative with new information.Upon review of the information received on 15-oct-2019, the coding for insulin lispro was updated from humalog to insulin lispro as per psp case.Edit 31-jul-2020: upon review of the information received on 27-jul-2020, pc# (b)(4) was received through action item.Processed pc# (b)(4) accordingly and attached related cire report to the case.No other changes were made to the case.Update 06-aug-2020: information was received from affiliate on 03-aug-2020 that included a trackwise number (b)(4).No medically significant information was added to the case.No changes were made.Update 06aug2020: additional information received on 06aug2020 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields/ european and canadian (eu/ca) device information, and device return status to not returned to manufacturer for pc (b)(4) associated with an unknown lot of a 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, ; 4334585
• MDR Report Key: 10379614
• MDR Text Key: 209560814
• Report Number: 1819470-2020-00096
• 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: 08/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• 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
• Date Manufacturer Received: 07/27/2020
• 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: 63 YR
• Patient Weight: 73