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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 Mechanical Problem (1384); Failure to Fire (2610)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Reportable malfunction/incident identified. Investigation in progress. A follow-up report will be submitted when the final evaluation is completed as necessary.
 
Event Description
Lilly case id: (b)(4). This report is associated with product complaint: (b)(4). This device case, which does not include an adverse event, reported by a consumer who contacted the company with a product complaint, concerns a patient of unknown gender, age, and ethnicity. The patient was taking insulin lispro via humapen ergo ii for the treatment of an unknown indication. The dose, route, frequency, indication for use, and start date were not provided. It was noted that the current pen was used for 8 years and the needle was on device after injection. On (b)(6) 2021, the daughter of the patient stated that the black stick in the pen became malfunctioned and that it was not proceeded by the pen crashing or falling down. It was noted that there was no swelling. Troubleshooting was performed and the dose knob went to zero, but the device did not give any drug. Bd microfine needle tip was suggested. This device was associated with product complaint (b)(4)/lot number 1501d02. The operator and training status of the user was unknown. The duration of use for the device model was unknown and the suspect pen was used for 8 years. The device was returned on 29jun2021 to the manufacturer and a new device was sent to patient. Edit 23jul2021: updated medwatch and european and (b)(6) 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)
TECH GROUP NORTH AMERICA INC. DBA WEST
640 south rockford drive
tempe AZ 85281
Manufacturer Contact
chris davis
lilly corporate center
indianapolis, IN 46285
3174334585
MDR Report Key12219623
MDR Text Key268078480
Report Number1819470-2021-00092
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 consumer,foreign
Type of Report Initial,Followup
Report Date 08/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberMS9557
Device Lot Number1501D02
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer06/29/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/06/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/31/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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