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U.S. Department of Health and Human Services

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

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ELI LILLY AND COMPANY HUMAPEN ERGO II FOR TREATMENT PURPOSES Back to Search Results
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.
 
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Brand NameHUMAPEN ERGO II
Type of DeviceFOR 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 Key8700327
MDR Text Key148182264
Report Number1819470-2019-00108
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K151686
Number of Events Reported1
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 Received06/14/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberMS9557
Device Lot Number1612D04
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/17/2019
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 Treatment Data
Date Received: 06/14/2019 Patient Sequence Number: 1
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