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

Model Number MS9696

Device Problems Break (1069); Defective Device (2588)

Patient Problems Erythema (1840); Itching Sensation (1943); Rash (2033)

Event Date 01/31/2015

Event Type  Injury  

Manufacturer Narrative

Narrative field; new updated and corrected information is referenced within the update statements in describe event or problem.No further follow up is planned.This report is associated with 1819470-2018-00068 since there is more than one device implicated.Evaluation summary: a female patient that reported that she could set the dose using her humapen savvio device but the device did not deliver the dose.She also reported that two to three years ago, one of the two savvio devices involved in this case "slipped through" and delivered more than the intended 30 ius.She experienced abnormal blood glucose.The device was not returned to the manufacturer for investigation (batch 1404v13, manufactured april 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 device not working 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.There is no evidence of improper use or storage.

Event Description

(b)(4).This spontaneous device only case, reported by a consumer who contacted the company to report adverse events and a product complaint (pc), concerned a female patient of an unknown age and origin.Medical history included cataract and increased blood pressure.Concomitant medications included verapamil, moxonidine and glyceryl trinitrate; all for unknown indication.The patient received an unspecified insulin via a reusable pen humapen savvio (green), subcutaneously, for the treatment of diabetes mellitus (dm), beginning on an unknown date.Since 2012, she had two humapen savvios and both were defective or broke (lot number: 1405v03, (b)(4) and lot number: 1404v13, (b)(4)).She could dial the units but could no longer trigger the humapen savvios.They were blocking despite of using new needles.On an unspecified date, with the parallel imports or re-imports of insulin, the contents were different and she developed itching with red spots and rashes.In 2015 (or 2016; conflicting information was provided), humapen savvio pulled through and she injected more than the intended 30 ius.She needed to stay at the hospital for the night and an electrocardiogram (ecg) was performed (results were unknown).She needed to monitor her blood glucose and it was controlled while in hospital.Meanwhile she had recovered everything as well and she could smile at it.However, at that time she had felt differently.Her blood glucose was hard to control.She sometimes developed values up to 400 mg/dl (specific value and reference range was not provided).On an unknown date, her blood pressure went up to 173/90 and the event was considered as serious by the company due to medically significant reasons.Information regarding corrective treatment of the events was not provided.She had recovered from the events of uncontrolled blood glucose and wrong dose and outcome of the remaining events was unknown.The status of unspecified insulin and humapen savvios was unknown.No additional follow up would be attempted since the consent to contact the reporting consumer or healthcare professional (hcp) was declined.Patient was the operator of the humapen savvios and her training status was not provided.The humapen savvios model duration of use and the suspect humapen savvios duration of use were not reported.The humapen savvios (green) were not returned to the manufacturer.The reporting consumer did not provide the opinion of relatedness between the events and the unspecified insulin and humapen savvios.The events of rash pruritic, rash erythematous and blood pressure increased were not associated with humapen savvios.Update 20apr2018: additional information received on 20apr2018 from the global product complaint database.Entered device specific safety summary (dsss); updated the medwatch and european and canadian (eu/ca) device fields; and added the date of manufacturer for the suspect humapen savvio green devices associated with (b)(4).Corresponding fields and narrative updated accordingly.Edit 20apr2018: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information was added.

• Brand Name: HUMAPEN SAVVIO 3ML (GREEN)
• 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: 7490160
• MDR Text Key: 107465009
• Report Number: 1819470-2018-00069
• 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: 05/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MS9696
• Device Lot Number: 1404V13
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2014
• 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
• Treatment: MOXONIDINE UNKNOWN; MOXONIDINE UNKNOWN; NITROLINGUAL UNKNOWN; VERAPAMIL UNKNOWN
• Patient Outcome(s): Hospitalization