FDA Adverse Event
Malfunction
Summary report: N
ORTHO PROVUE
MDR report key: 3013126
·
Received March 20, 2013
Report
- Report Number
- 1056600-2013-00010
- Event Type
- Malfunction
- Date Received
- March 20, 2013
- Date of Event
- February 12, 2013
- Report Date
- March 20, 2013
- Manufacturer
- MICROTYPING SYSTEMS
- Product Code
- KSZ
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INSTRUMENT HAS BEEN INVESTIGATED. ON (B)(4) 2013 AN OCD FIELD ENGINEER (FE) ARRIVED AT THE CUSTOMER SITE AND FOUND ONE OF THE GRIPPER PIN CIRCLIPS MISSING. THE FE REPLACED THE GRIPPER PIN CIRCLIPS. THE FE ALSO FOUND THE SYRINGE TO BE WORN. THE FE REPLACED THE SYRINGE. THE FE RAN THE WADDIAGNOSTIC TOOL. ALL TEST PASSED WITHOUT ERROR. REPAIRS HAVE RETURNED THIS INSTRUMENT TO EXPECTED OPERATION. (B)(4).
Description of Event or Problem · 1
THE CUSTOMER REPORTS THAT THEY RECEIVED FALSE NEGATIVE RESULTS FROM THE ORTHO PROVUE WHILE PERFORMING CORRELATION STUDIES DURING VALIDATION (MULTIPLE SAMPLES RUN AND REPEAT TESTING DONE FOR TROUBLESHOOTING PURPOSE). NO ERRONEOUS RESULTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 116644 | ORTHO PROVUE | AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM | KSZ | MICROTYPING SYSTEMS | 3.2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |