FDA Adverse Event
Malfunction
Summary report: N
ORTHO PROVUE ANALYZER
MDR report key: 789084
·
Received November 22, 2006
Report
- Report Number
- 1056600-2006-00343
- Event Type
- Malfunction
- Date Received
- November 22, 2006
- Date of Event
- October 27, 2006
- Report Date
- November 22, 2006
- Manufacturer
- MICRO TYPING SYSTEMS, INC.
- Product Code
- KSZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- INVALID DATA
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER REPORTED THAT THEY HAD OBSERVED FLUID DRIPPING FROM THE PROBE OF THE ORTHO PROVUE ANALYZER. AN OCD FILED ENGINEER (FE) ARRIVED ON SITE. THE FE PERFORMED REPAIRS AND THE APPROPRIATE ADJUSTMENTS TO RETURN THE ANALYZER TO EXPECTED OPERATION. PROBE DIP CAN LEAD TO CARRY OVER OR CROSS CONTAMINATION FROM MICROTUBE TO MICROTUBE OR DILUTION OF REAGENT OR SAMPLE. BASED ON THE AVAILABLE INFO, MTS COULD NOT RULE OUT PROVUE MALFUNCTION AS A CONTRIBUTING FACTOR. IF THIS INCIDENT WERE TO RECUR UNDETECTED, ERRONEOUS RESULTS MAY OCCUR, LEADING TO POSSIBLE TRANSFUSION OF INCOMPATIBLE BLOOD. STN# BK030023.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THEY HAD OBSERVED FLUID DRIPPING FROM THE PROBE OF THE ORTHO PROVUE ANALYZER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ORTHO PROVUE ANALYZER | AUTOMATED BLOOD GROUPING AND ANTIBODY TE | KSZ | MICRO TYPING SYSTEMS, INC. | MTS213784 | 2.15 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |