FDA Adverse Event
Malfunction
Summary report: N
HUMAPEN ERGO, TEAL/CLEAR
MDR report key: 498667
·
Received November 21, 2003
Report
- Report Number
- 1819470-2003-00041
- Event Type
- Malfunction
- Date Received
- November 21, 2003
- Report Date
- November 3, 2003
- Manufacturer
- ELI LILLY AND CO.
- Product Code
- FMF
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- NO INFORMATION
Narratives
Description of Event or Problem · 1
THE PATIENT WAS TAKING AN UNSPECIFIED MEDICATION VIA A HUMAPEN ERGO TEAL PEN WITH CLEAR CARTRIDGE HOLDER (LOT NUMBER A1495) FOR AN UNKNOWN INDICATION. THE PERSON OPERATING THE DEVICE WAS THE PATIENT. IT IS UNKNOWN IF THE OPERATOR OF THE DEVICE WAS TRAINED. THE PEN WAS REPORTED WITH A NON-SPECIFIC COMPLAINT. THE DEVICE WAS RETURNED TO THE COMPANY FOR ANALYSIS. INITIAL ANALYSIS BY THE AFFILATE QUALITY CONTROL DEPARTMENT FOUND: BROKEN ENGAGEMENT TABS. THE PRODUCT IS OUT OF SPECIFICATION FOR DOSE ACCURACY. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR ADDITIONAL EVALUATION. REFER TO THE RESULTS/CONCLUSION SECTION FOR INVESTIGATION CONCLUSION INFORMATION PROVIDED BY THE DEVICE MANUFACTURING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HUMAPEN ERGO, TEAL/CLEAR | PEN INJECTOR | FMF | ELI LILLY AND CO. | MS8929 | A1495 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO |