FDA Adverse Event
Malfunction
Summary report: N
ORTHO SUMMIT PLUS
MDR report key: 1476000
·
Received September 1, 2009
Report
- Report Number
- 2250051-2009-00271
- Event Type
- Malfunction
- Date Received
- September 1, 2009
- Date of Event
- August 27, 2009
- Report Date
- September 2, 2009
- Manufacturer
- HAMILTON BONADUZ AG
- Product Code
- JTC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT. THE FSE INSPECTED THE INSTRUMENT AND FOUND ALL TIP CLAMPS AND PLUNGER CLAMPS IN GOOD CONDITION AS WELL AS ALL HOLDING FORCES, PROPER TIP PICK UP AND ALL ALIGNMENTS. FSE SUCCESSFULLY PERFORMED A PRE-SERVICE VOLUME VERIFICATION WHICH PASSED ALL PARAMETERS. INSTRUMENT IS WORKING AS EXPECTED, NO REPAIR WERE NECESSARY.
Description of Event or Problem · 1
THE ORTHO SUMMIT SAMPLE HANDLING SYS INSTRUMENT DID NOT PIPETTE REAGENT AND DID NOT GENERATE AN ERROR MESSAGE. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS INCIDENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B) (4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ORTHO SUMMIT PLUS | SAMPLE PIPETTER | JTC | HAMILTON BONADUZ AG | 142036 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |