FDA Adverse Event
Malfunction
Summary report: N
MICROLAB AT PLUS 2
MDR report key: 883576
·
Received September 28, 2006
Report
- Report Number
- 2915796-2006-00007
- Event Type
- Malfunction
- Date Received
- September 28, 2006
- Date of Event
- August 23, 2006
- Report Date
- September 28, 2006
- Manufacturer
- HAMILTON BONADUZ AG
- Product Code
- JTC
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
OUR DISTRIBUTOR FOR THE DEVICE, ORTHO-CLINICAL DIAGNOSTICS, HAS INVESTIGATED THIS EVENT AND HAS EVALUATED THE INSTRUMENT. THE INSTRUMENT WAS FOUND TO HAVE BEEN CONTAMINATED, CONTRIBUTING TO THE EVENT. THE INSTRUMENT HAS BEEN REPAIRED AND CLEANED, AND RETURNED TO SERVICE.
Description of Event or Problem · 1
HAMILTON CO WAS INFORMED OF AN EVENT THAT OCCURRED IN 2006, IN WHICH THE HAMILTON MICROLAB AT +2 INSTRUMENT REPORTEDLY MISSED PIPETTING A SAMPLE AND DID NOT POST EN ERROR MESSAGE. NO DEATH OR INJURY RESULTED FROM THIS EVENT. THIS REPORT IS ASSOCIATED WITH HAMILTON CUSTOMER.
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 |