FDA Adverse Event
Malfunction
Summary report: N
ORTHO PROVUE
MDR report key: 3851288
·
Received June 5, 2014
Report
- Report Number
- 1056600-2014-00034
- Event Type
- Malfunction
- Date Received
- June 5, 2014
- Date of Event
- May 22, 2014
- Report Date
- June 5, 2014
- Manufacturer
- MICROTYPING SYSTEMS
- Product Code
- KSZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ON 05-23-2014 AN OCD FIELD ENGINEER (FE) ARRIVED AT THE CUSTOMER SITE AND FOUND CAMERA BRIGHTNESS HAD SHIFTED SINCE LAST ADJUSTED. TO SOLVE THE ISSUE, ALL READER CAMERA ADJUSTMENT WERE PERFORMED AND A NEW IMAGE WAS GENERATED. AFTER COMPLETION OF SERVICE CUSTOMER RAN CONTROLS AND SAMPLE THAT PROVIDED THE NEGATIVE RESULT. ALL CONTROL RESULTS WERE ACCEPTABLE AND THE SAMPLE GAVE A POSITIVE RESULT. REPAIRS HAVE RETURNED THIS INSTRUMENT TO EXPECTED OPERATION.
Description of Event or Problem · 1
THE CUSTOMER REPORTS A FALSE NEGATIVE INTERPRETATION BY THE PROVUE'S GEL CAMERA TO A VISUALLY CONFIRMED W-1+ REACTION TO A PATIENT'S ANTIBODY SCREEN. NO INCORRECT OR ERRONEOUS RESULTS WERE REPORTED. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 329167 | ORTHO PROVUE | AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM | KSZ | MICROTYPING SYSTEMS | 3.2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |