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

Model Number MS9557

Device Problems Failure to Deliver (2338); Difficult to Advance (2920)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Manufacturer Narrative

If device is returned, evaluation will be performed to determine if a malfunction has occurred.This is an initial report.A report will be submitted when the final evaluation has been completed.

Event Description

Lilly case id: (b)(4).This report is associated with product compliant: (b)(4).This device only solicited case reported by a consumer via a patient support program (psp), concerned a patient of unknown gender, age and ethnicity.Medical history included hospitalization on (b)(6) 2018 for an unspecified reason.Concomitant medications included insulin glargine, as well as three unspecified oral medications; for an unknown indication.Historical drugs included insulin lispro (humalog) for the treatment of diabetes mellitus.The patient received unknown insulin via a reusable pen (humapen ergo ii) from (b)(6) 2018, subcutaneously, for diabetes mellitus, beginning on an unknown date.Dosing regimen was not provided.On an unknown date, while using humapen ergo ii with unknown medication, patient experienced high blood sugar and poor control (units and values were not provided); therefore on (b)(6) 2019 the patient was hospitalized, and reportedly the patient started insulin lispro (humalog) again after hospitalization.Furthermore, on (b)(6) 2019 the injection screw of the humapen ergo ii could not move while the injection button could be pushed down which led to the humapen ergo ii could not push insulin out.The hotline agent inquired relevant situation and helped prime by phone.The patient changed a new needle and an insulin cartridge, primed but no insulin flowed out, the prime failed ((b)(4), lot no.1612d04).Information regarding corrective treatment, outcome of the event, laboratory data and hospitalization discharge date was not provided.Status of unknown insulin was not provided.The humapen ergo ii pen was used until (b)(6) 2019.The operator of the humapen ergo ii and her/his training status were unknown.The humapen ergo ii model duration of use and the suspect humapen ergo ii duration of use were not reported but it was started on (b)(6) 2018.The action taken and returns status of the device were unknown.The reporting consumer did not provide an opinion of relatedness between the event and humapen ergo ii.Update 23-may-2019: initial informant and follow-up information both received on 17-may-2019 were processed at the same time.Update 24-may-2019: additional information received from the affiliate on (b)(6) 2019.Reported that the patient administered insulin glargine as well as three oral medications and was attempted to provide the specific name of the medications, but was not provided.No changes were made to the case.Edit 29may2019: updated medwatch and european and (b)(4) (eu/(b)(4)) fields for expedited device reporting.No new information added.

• 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: chris davis ; lilly corporate center; indianapolis, IN 46285 ; 3174334585
• MDR Report Key: 8700327
• MDR Text Key: 148182264
• Report Number: 1819470-2019-00108
• 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: company representative,consum
• Type of Report: Initial
• Report Date: 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS9557
• Device Lot Number: 1612D04
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/17/2019
• Was Device Evaluated by Manufacturer?: No
• 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