FDA Adverse Event
Malfunction
Summary report: N
MICROLAB AT PLUS 2
MDR report key: 413098
·
Received August 23, 2002
Report
- Report Number
- 2915796-2002-00026
- Event Type
- Malfunction
- Date Received
- August 23, 2002
- Date of Event
- May 6, 2002
- Report Date
- August 23, 2002
- Manufacturer
- HAMILTON BONADUZ AG
- Product Code
- JTC
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
HAMILTON COMPANY WAS INFORMED ON JULY 24, 2002 OF AN EVENT THAT OCCURRED IN 2002, IN WHICH THE HAMILTON MICROLAB AT +2 INSTRUMENT REPORTED A "HEART" SYMBOL INSTEAD OF THE CORRECT BARCODE LABEL IDENTIFICATION. NO DEATH OR INJURY RESULTED FROM THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MICROLAB AT PLUS 2 | MICROTITER DILUTING/DISPENSING | JTC | HAMILTON BONADUZ AG | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |