FDA Adverse Event
Malfunction
Summary report: N
ORTHO PROVUE
MDR report key: 1111614
·
Received August 13, 2008
Report
- Report Number
- 1056600-2008-00261
- Event Type
- Malfunction
- Date Received
- August 13, 2008
- Date of Event
- July 19, 2008
- Report Date
- August 13, 2008
- Manufacturer
- MICRO TYPING SYSTEMS, INC.
- Product Code
- KSZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO DEFINITE ROOT CAUSE WAS DETERMINED. AN OCD FE INSPECTED THE INSTRUMENT AND REPLACED THE O-RINGS ON THE WASTE BOTTLE AND REPLACED THE ELECTROVALVES. THE INSTRUMENT WAS RETURNED TO EXPECTED OPERATION. THIS CUSTOMER HAS NOT LOGGED ANY COMPLAINTS AGAINST THIS ANALYZER SINCE THIS INCIDENT.
Description of Event or Problem · 1
CUSTOMER REPORTED A WASH STATION OVERFLOW. THE FE CALLED BACK TO REPORT THAT THE PROBE WAS DRIPPING AND THAT THE REAGENTS WERE CONTAMINATED. NO ERROR CODES WERE POSTED BY THE PROVUE. THERE WAS NO BIOHAZARD EXPOSURE AND NO ERRONEOUS RESULTS WERE REPORTED. PROBE DRIP MAY LEAD TO DILUTION OF SAMPLE/REAGENT, CARRY OVER AND/OR CROSS CONTAMINATION AND ERRONEOUS RESULTS WHICH COULD LEAD TO TRANSFUSION OF INCOMPATIBLE BLOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ORTHO PROVUE | AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYST | KSZ | MICRO TYPING SYSTEMS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |