FDA Adverse Event
Malfunction
Summary report: N
ORTHO PROVUE
MDR report key: 1053198
·
Received May 28, 2008
Report
- Report Number
- 1056600-2008-00179
- Event Type
- Malfunction
- Date Received
- May 28, 2008
- Date of Event
- May 1, 2008
- Report Date
- May 28, 2008
- Manufacturer
- MICRO TYPING SYSTEMS, INC.
- Product Code
- KSZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO DEFINITIVE ROOT CAUSE WAS DETERMINED. SERVICE WAS NOT DISPATCHED SINCE THE PROVUE HAND HELD SCANNER WAS UNABLE TO READ THE SAMPLE BARCODES AND THE ANALYZER MISREAD THE BARCODE UPON SECOND ATTEMPT. THE ISSUE MAY HAVE BEEN RELATED TO THE SAMPLE BARCODES. THIS CUSTOMER HAS NOT LOGGED ANY SIMILAR COMPLAINTS AGAINST THIS ANALYZER SINCE THIS INCIDENT. INCIDENT IS ISOLATED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE ORTHO PROVUE READ A SAMPLE BARCODE ID INCORRECTLY. SAMPLE MISIDENTIFICATION MAY LEAD TO THE REPORTING OF ERRONEOUS TEST RESULTS. THE CUSTOMER IDENTIFIED THE ISSUE, PREVENTING ERRONEOUS RESULTS FROM BEING REPORTED.
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. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |