MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN ERGO II; FOR TREATMENT PURPOSES

Model Number MS9557

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Hypoglycemia (1912); Vomiting (2144); Coma (2417)

Event Date 07/08/2017

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 reported the injection button of his humapen ergo ii device "stopped at the 1 position" during the injection.The patient also indicated the injection force was sometimes high.The patient experienced hypoglycemic coma.The device was not returned to the manufacturer for investigation (batch number 1310d01, manufactured october 2013).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.A complaint history review of this batch did not identify any atypical findings with regard to jammed pens.All humapen ergo ii 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 case, reported by a consumer who contacted the company to report adverse events and product complaint (pc), with additional information from the initial reporter, concerns a (b)(6) male patient of unknown origin.Medical history was not provided.Concomitant medications included glargine insulin for unknown indication.The patient received insulin lispro (rdna origin) (humalog) from a cartridge via a reusable pen (humapen ergo ii) 10 u at morning, 10 at noon and 10 at evening subcutaneously for the treatment of diabetes mellitus beginning in 2015.Reportedly, the number in the dose window of the humapen ergo ii could not be adjusted to zero during the injection and stopped at the one position.In addition, the injection force was sometimes high in (b)(6) 2017.Further described, the injection button could not be pushed down after the patient changed needles ((b)(4)/ lot number 1310d01).On (b)(6) 2017, after insulin lispro injection, he ate less and vomited.It caused hypoglycemia and coma.Insulin lispro was discontinued on (b)(6) 2017.Then he was sent to hospital and on (b)(6) 2017 he was hospitalized in ward.It was unknown if he received any corrective treatment.Outcome of the events were unknown.Insulin lispro therapy was restarted on (b)(6) 2017 at night and continued.The operator of the device and his training status were unknown.The general device model duration of use was not known.The suspect device duration of use was approximately one year.Action taken with suspect device was not provided; the suspect device was not returned to the manufacturer.The reporting consumer was unknown if the events were related to insulin lispro therapy or device.Update 19-jul-2017: additional information received from the initial reporter.No med sig information was provided.Narrative was updated.Update 26jul2017: updated medwatch fields for expedited device reporting.Upon internal review, added the product complaint number and description to the narrative.Update 07aug2017: additional information received on 04aug2017 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch/european and canadian (eu/ca) device field information and device return status to not returned to manufacturer.Added date of manufacturer for (b)(4) associated with device humapen ergo ii.Corresponding fields and narrative updated accordingly.

• Brand Name: HUMAPEN ERGO II
• 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; 415 red cedar street; medical device manufacturing; menomonie WI 54751
• Manufacturer Contact: caroline rosewell ; lilly corporate center; indianapolis, IN 46285 ; 3172764376
• MDR Report Key: 6774296
• MDR Text Key: 82065627
• Report Number: 1819470-2017-00128
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K151686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial
• Report Date: 08/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MS9557
• Device Lot Number: 1310D01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2013
• 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
• Treatment: HUMALOG LISPRO (LISPRO LISPRO) CARTRIDGE; INSULIN GLARGINE
• Patient Outcome(s): Hospitalization
• Patient Age: 73 YR