FDA Adverse Event
Malfunction
Summary report: N
ORTHO PROVUE
MDR report key: 2111751
·
Received June 2, 2011
Report
- Report Number
- 1056600-2011-00052
- Event Type
- Malfunction
- Date Received
- June 2, 2011
- Date of Event
- May 9, 2011
- Report Date
- June 2, 2011
- Manufacturer
- MICROTYPING SYSTEMS
- Product Code
- KSZ
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN OCD FIELD ENGINEER (FE) ARRIVED AT THE CUSTOMER SITE AND REPLACED THE BROKEN SAMPLE TUBE SIDE SPRING ASSEMBLY. THE FE ALSO PERFORMED A PM AS PER CHECKLIST. THE CUSTOMER RAN AND PASSED QC. REPAIRS HAVE RETURNED THE INSTRUMENT TO EXPECTED OPERATION. (B)(4).
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE ORTHO PROVUE MISSED AN ANTIBODY THAT WAS DETECTED IN MANUAL GEL. NO ERRONEOUS RESULTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ORTHO PROVUE | AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM | KSZ | MICROTYPING SYSTEMS | 3.1.1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |