FDA Adverse Event
Malfunction
Summary report: N
ORTHO PROVUE ANALYZER
MDR report key: 810951
·
Received October 26, 2006
Report
- Report Number
- 1056600-2006-00221
- Event Type
- Malfunction
- Date Received
- October 26, 2006
- Date of Event
- October 17, 2005
- Report Date
- October 26, 2006
- Manufacturer
- MICRO TYPING SYSTEMS, INC.
- Product Code
- KSZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- NO INFORMATION
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION INTO THIS EVENT BY THE FIELD ENGINEER CONFIRMED THE CUSTOMER'S COMPLAINT. THE FE REPLACED THE WASH STATION, PRESSURE REGULATOR AND TUBING AND RESTORED THE ANALYZER TO PROPER OPERATION. HOWEVER, THE ROOT CAUSE OF THE EVENT WAS NOT DETERMINED.
Description of Event or Problem · 1
THE CUSTOMER OBSERVED FLUID DRIPPING FROM THE WASH STATION INSIDE THE ROBOTIC HANDLER OF THE ORTHO PROVUE ANALYZER. DRIPPING FLUID MAY LEAD TO DILUTION OF REAGENT OR SAMPLE AND MAY LEAD TO ERRONEOUS TEST RESULTS. THERE WAS NO REPORT OF HARM AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ORTHO PROVUE ANALYZER | AUTOMATED BLOOD GROUPING AND ANTIBODY TEST SYSTEM | KSZ | MICRO TYPING SYSTEMS, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |