FDA Adverse Event
Malfunction
Summary report: N
MICROLAB AT PLUS 2
MDR report key: 456874
·
Received April 24, 2003
Report
- Report Number
- 2915796-2003-00013
- Event Type
- Malfunction
- Date Received
- April 24, 2003
- Date of Event
- March 26, 2003
- Report Date
- April 24, 2003
- 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 CO WAS INFORMED IN MARCH 2003 OF AN EVENT THAT OCCURRED IN 2003, IN WHICH THE HAMILTON MICROLAB AT +2 INSTRUMENT REPORTEDLY DOUBLE-SCANNED SAMPLES IN C4/D4, C6/D6, D8/E8, AND C9/D9 (RE-READ WRONG ROWS) AND DID NOT GENERATE AN ERROR MESSAGE. 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 |