FDA Adverse Event
Malfunction
Summary report: N
ORTHO PROVUE ANALYZER
MDR report key: 717020
·
Received November 17, 2005
Report
- Report Number
- 1056600-2005-00131
- Event Type
- Malfunction
- Date Received
- November 17, 2005
- Date of Event
- October 19, 2005
- Report Date
- November 17, 2005
- Manufacturer
- MICRO TYPING SYSTEMS, INC.
- Product Code
- KSZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
CUSTOMER STATED THAT THE PROVUE ANALYZER PROBE WAS DRIPPING. AN OCD FIELD ENGINEER (FE) VISITED THE SITE ON 10/19/2005. THE FE FOUND THAT THE PRESSURE SETTING OF THE FLUIDICS SYSTEM WAS OUT OF SPECIFICATION RESULTING IN PROBE DRIP. THE FE REPLACED THE PRESSURE REGULATOR AND PERFORMED THE APPROPRIATE ADJUSTMENTS. REPAIRS HAVE RETURNED THIS ANALYZER TO EXPECTED OPERATION. NO ERRONEOUS RESULTS WERE REPORTED AS A RESULT OF THIS INCIDENT.
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. | MTS213784 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |