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

Model Number MS9697

Device Problems Device Inoperable (1663); Defective Component (2292); Failure to Deliver (2338)

Patient Problems Syncope (1610); Hypoglycemia (1912); Swelling (2091); Coma (2417); Sweating (2444)

Event Date 03/28/2018

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 daughter reported on behalf of a female patient that since (b)(6) 2018 the injection button of the patient's humapen savvio device was not working and the insulin could not be released.On (b)(6) 2018, the patient experienced hypoglycemic coma.The device was not returned to the manufacturer for investigation (batch 1309v06, manufactured september 2013).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 issues.All humapen savvio devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality with high probability.There is no evidence of improper use or storage.

Event Description

(b)(4).This solicited case reported by a consumer via a patient support program (psp), with additional information received from an additional consumer via the psp, concerned a (b)(6) female patient of an unknown origin.Medical history included unspecified heart disease and blood pressure problems.She could not read or write.Concomitant medications included unspecified medications for the treatment of unknown heart disease and blood pressure (as reported).The patient received insulin lispro (rdna origin) injections (humalog 100 u/ml) via a cartridge from a reusable humapen savvio (pink), 50 international units (iu) at morning and 40 iu at night, subcutaneously, for the treatment of diabetes mellitus beginning in 2009.On an unknown date in (b)(6) 2018, while on insulin lispro therapy, her legs became swollen and she would have some tests performed.Since (b)(6) 2018, she had been administering nothing as the insulin lispro dose was not released from the humapen savvio because the injection button was not working and the dose could not be released from the pen, although the needles and cartridges were changed several times ((b)(4), lot: 1309v06).On (b)(6) 2018, while not being on insulin lispro treatment due to humapen savvio issue, she was sweaty and had a diabetic coma because her blood sugar was very low.She fainted but she did not lose consciousness as she was aware of the surroundings, she was able to see people around her but was not able to talk to them.She did not know for how long that incident lasted and did not experience any injuries.She did not require emergency services or hospital admission and when her daughter gave her a glass of water with sugar, she recovered and after a while she became fine but she did not measure her blood glucose level.The event of hypoglycemic coma was considered serious by the company due to medically significant reasons.As of (b)(6) 2018, she recently measured her blood glucose level and it was controlled, hence she began to use insulin lispro treatment from syringes till the humapen savvio would be replaced.Information regarding corrective treatment and outcome of the remaining events was not provided.Insulin lispro therapy was continued.The daughter of the patient was the operator of the humapen savvio and her training status was not provided.The humapen savvio model duration of use and the suspect humapen savvio duration of use were not provided.The suspect humapen savvio, which was manufactured in sep2013, was discontinued and not returned to the manufacturer.The reporting consumers did not provide an assessment of relatedness between the events and insulin lispro therapy or humapen savvio device.Edit 06apr2018: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 11-apr-2018: additional information received on 07-apr-2018, from affiliate via psp.Added medical history.Narrative was updated.Update 16-apr-2018: additional information was received on 11-apr-2018 from an additional consumer via the psp in response to follow up questions.Added consumer as a reporter, medical history of not being able to read or write, lab test of blood glucose and one serious event of syncope.Updated the seriousness of the event hypoglycemic coma from life threatening to medically significant, outcome of the events hypoglycemic coma and missed dose from unknown to resolved, description as reported of the event missed dose, causality statement and narrative with the new information.Update 20-apr-2018: upon clarification by the local affiliate of the information initially received on 11-apr-2018, updated the description as reported for the event of hypoglycemic coma and missed dose.Upon follow up received the event of fainted but was aware of the surroundings was deleted as it was features of hypoglycemic coma.Updated the narrative accordingly.Update 24apr2018: additional information received on 19apr2018 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 1309v06 of humapen savvio (pink) device.Corresponding fields and narrative updated accordingly.

• Brand Name: HUMAPEN SAVVIO 3ML (PINK)
• 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: 7457445
• MDR Text Key: 106395011
• Report Number: 1819470-2018-00056
• 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: company representative,consum
• Type of Report: Initial
• Report Date: 04/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MS9697
• Device Lot Number: 1309V06
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2013
• 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: 65 YR