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

Model Number MS9698

Device Problems Crack (1135); Failure to Deliver (2338); Mechanical Jam (2983)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

No further follow-up is planned.This report is associated with 1819470-2017-00176, since there is more than one device implicated.Evaluation summary: the niece of a male patient reported that his humapen savvio device was jammed, and the cartridge holder was broken and was not attaching to pen body.The patient missed his insulin dose and experienced abnormal blood glucose levels.The device was not returned to the manufacturer for investigation (batch 1503v03, manufactured march 2015).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.Photographs of the cartridge holder provided by the reporter were examined.The examination could not conclusively determine any breaks or abnormalities associated with the cartridge holder.A complaint history review for the batch did not identify any atypical findings with respect device not working.There is no evidence of improper use or storage.

Event Description

Lilly case id: (b)(6).This report is associated with product compliant: (b)(4).This spontaneous case, reported by a consumer, who contacted the company to report a product complaint, concerns male patient of unspecified age and ethnicity.Medical history and concomitant medications were not reported.The patient received human insulin (rdna origin) nph (humulin n) cartridge and human insulin (rdna origin) regular (humulin r) cartridge, unknown dose, frequency, route of administration, indication for use and start date.On an unspecified date, unspecified time after starting human insulin nph and human insulin regular via humapen savvio red 3ml (lot number 1406v08), humapen savvio graphite 3ml (lot number 1503v03) and humapen luxura half-dose (lot number 1402g05), the patient did not receive insulin for one day due to devices problems.The patient was hospitalized due to uncontrolled glycaemia (unspecified date), reported as uncontrolled diabetes.The patient was hospitalized for 20 days and was discharged when was recovered.The reporter stated that humapen savvio red 3ml was jammed and insulin was not coming out (product complaint number (b)(4)/ lot number 1406v08), the humapen savvio graphite was jammed and the cartridge holder was cracked and it was not attaching to pen body (product complaint number (b)(4)) and the humapen luxura half-dose was jammed and almost broken (product complaint number (b)(4)/ lot number 1402g05).Further information regarding laboratory exams, corrective treatment and outcome was not reported.As of (b)(6) 2017, the patient was using new devices (unspecified) and would have to come back to hospital on (b)(6) 2017 due to diabetes (as reported).No other information was provided.Human insulin nph and human insulin regular therapies status were not reported.It was unknown operated the devices and if operator was trained.It was unknown for how long the patient had used both devices models.The patient had used the reported devices humapen savvio red 3ml (lot number 1406v08) for six months, humapen savvio graphite 3ml (lot number 1503v03) for unspecified time and humapen luxura half-dose (lot number 1402g05) for three weeks.The humapen savvio red was returned on 15aug2017.The humapen savvio graphite 3ml and humapen luxura half-dose would not be returned.The reporting consumer did not relate the event of uncontrolled glycaemia to human insulin nph and human insulin regular, but related it and the dose omission to problem with devices.No other opinion of relatedness was provided.Update 02aug2017: additional information received on 01aug2017 from initial reporting consumer.Added humapen savvio 3ml (graphite) and humapen luxura hd as concomitant devices.Added new batch number for humulin n and humulin r as suspect product.Updated corresponding fields and narrative accordingly.Update 10aug2017: additional information received on 09aug2017 from call center.No new information was added to the case.The case remain non valid.Update 04sep2017: this case was initially determined to be non-valid (no adverse event).Additional information received from the initial reporter on 31aug2017 and 01sep2017, which contained valid event.Updated humapen savvio red, humapen savvio gray and humapen luxura hd to suspect devices.Added serious event of glycemia uncontrolled and non-serious event of missed dose.Updated corresponding fields and narrative accordingly.Edit 11sep2017: upon internal review, updated the lot number from 1406v01 to 1406v08 for product complaint (b)(4) relating to the humapen savvio red.No new information was added.Corresponding fields and narrative updated accordingly.Update 17sep2017: additional information received on 14sep2017 from the global product complaint database.Entered device specific safety summary (dsss); updated the medwatch fields with device information, the european and (b)(4) (eu/(b)(4)) device information; and added date of manufacturer for the suspect humapen luxura half dose device relating to product complaint (pc) (b)(4).Entered device specific safety summary (dsss); updated the medwatch fields with device information, the european and (b)(4) (eu/(b)(4)) device information, malfunction from unknown to no, and device return status to returned to manufacturer; added date of manufacturer and date returned to manufacturer for the device for the suspect humapen savvio red device relating to product complaint (pc) (b)(4).Corresponding fields and narrative updated accordingly.Update 25sep2017: additional information received on 25sep2017 from the global product complaint database.Entered device specific safety summary (dsss); updated the medwatch fields with device information and the european and (b)(4) (eu/(b)(4)) device information; and added date of manufacturer for the suspect humapen savvio graphite device relating to product complaint (pc) (b)(4).Corresponding fields and narrative updated accordingly.

• Brand Name: HUMAPEN SAVVIO 3ML (GRAPHITE)
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• Manufacturer (Section G): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• Manufacturer Contact: caroline rosewell ; lilly corporate center; indianapolis, IN 46285 ; 3172764376
• MDR Report Key: 6905388
• MDR Text Key: 87879530
• Report Number: 1819470-2017-00174
• 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: 09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MS9698
• Device Lot Number: 1503V03
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2015
• 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