MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN SAVVIO 3ML (RED); FOR TREATMENT PURPOSES

Model Number MS9694

Device Problems Use of Device Problem (1670); Device Operates Differently Than Expected (2913); Infusion or Flow Problem (2964); Mechanical Jam (2983)

Patient Problems Hypoglycemia (1912); Shock, Insulin (2264); Loss of consciousness (2418)

Event Date 01/31/2018

Event Type  Injury  

Manufacturer Narrative

New, updated and corrected information is referenced within the update statements in describe event or problem.No further follow-up is planned.Evaluation summary: a male patient that his humapen savvio device was jamming at the 2 unit mark when the dose was injected.The patient experienced a serious event of hypoglycemic unconsciousness and a non-serious event of diabetes mellitus inadequate control.The device was not returned to the manufacturer for investigation (batch 1410v01, manufactured october 2014).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.A complaint history review of the batch did not identify any atypical findings with respect to pen jam or dose accuracy issues.All humapen savvio 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 also reported using needles two to three times and storing the device in the refrigerator with the needle attached.The core user manual instructs to use a new needle for each injection and to not store the pen in a refrigerator.There is evidence of improper use and storage.The patient reused needles and stored the humapen savvio device in the refrigerator.It is not likely that these misuses are relevant to the event of hypoglycemic unconsciousness, but these misuses may be relevant to the non-serious event of diabetes mellitus inadequate control.

Event Description

(b)(4).This spontaneous case, reported by a consumer who contacted the company for a product complaint (pc) with additional information from another consumer, concerns a (b)(6) male patient of unknown ethnicity.Medical history included historical use of glibenclamide, leading to lack of drug effect and a prostate surgery in 2016.Concomitant medications included amlodipine, enalapril, atenolol, metformin and crataegus spp.Extract for unknown indication.The patient received insulin human regular (humulin r) for diabetic shock and insulin human nph (initially reported as novolin n, reported as humulin n via follow-up) for diabetes, both via a reusable humapen savvio (red) device unknown dose, frequency and route, starting around (b)(6) 2018.The patient purchased the humapen savvio (red) device in approximately (b)(6) 2018; two months prior to this initial report.In (b)(6) 2018, unknown if during or prior to insulin human nph therapy starting and before insulin human regular therapy starting, the patient experienced a diabetic shock, consisting of hypoglycemic unconsciousness and blood glucose at 600 (reference ranges not provided), considered as serious by the company due to medical significance (initially reported patient received only glibenclamide, but later it was reported via follow-up that patient received insulin therapy at the time of event).It was noted that after he switched to insulin the glucose was not normalizing.Furthermore, the patient was reported to have forgotten to take his insulin dose and to eat before the event.Corrective treatment included honey and a shot of insulin human regular (humulin r).The patient was recovered from the event a few hours after treatment.On an unknown date, during therapy via a humapen savvio (red) pen, the patient experienced a wrong dose administered due to device issue.The device was reported to get stuck, jammed with 2 iu remaining for injection ((b)(4)/lot 1410v01).The device was reported to be stored in the refrigerator with an attached needle and that patient reused needles two to three times.Laboratorial results, corrective treatment and outcome were not provided.The patient was reported to not receive insulin human regular anymore, since it was mostly used as corrective treatment for the historical event.Insulin human nph therapy status was unknown.The device was operated by the patient, however it was unknown if he received training.The device model duration of use was not provided.The reported device was in use for two months.The suspect device with (b)(4), which was manufactured in oct2014, was not returned to the manufacturer.The reporting consumers provided no relatedness assessment.Update: follow-up received on 20mar2018 was processed within initial case entry.Update 29mar2018: additional information was received on 28mar2018 from the second reporting consumer.Updated case priority.Added prostate surgery as medical history.Added lack of drug effect as historical glibenclamide reaction.Removed hypoglycemic unconsciousness as medical history.Added humulin n suspect drug.Added amlodipine (amlodipino), enalapril, atenolol, metformin (metformina) and crataegus spp.Extract (sencor) as concomitant medication.Added humulin r indication and start date.Added hypoglycemic unconsciousness serious event and diabetes mellitus inadequate control non-serious event.Updated narrative and corresponding fields accordingly.Update 13apr2018: additional information received on 12apr2018 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch/european and canadian (eu/ca) device information and device return status to not returned to manufacturer.Added date of manufacturer for (b)(4) associated with lot 1410v01 of a humapen savvio (red) device.Corresponding fields and narrative updated accordingly.Edit 17apr2018: upon internal review, the follow-up receipt date of 28mar2018 was added for expedited reporting purposes.Edit 23apr018: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.

• Brand Name: HUMAPEN SAVVIO 3ML (RED)
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• Manufacturer (Section G): PHILLIPS-MEDISIZE CORPORATION; medical device manufacturing; 415 red cedar street; menomonie WI 54751
• Manufacturer Contact: chris davis ; lilly corporate center; indianapolis, IN 46285 ; 3174334585
• MDR Report Key: 7457626
• MDR Text Key: 106402818
• Report Number: 1819470-2018-00065
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K160668
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial
• Report Date: 04/25/2018

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MS9694
• Device Lot Number: 1410V01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/28/2018
• Initial Date FDA Received: 04/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2014
• 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
• Patient Age: 72 YR