FDA Adverse Event
Malfunction
Summary report: N
0.8% RESOLVE PANEL A
MDR report key: 2050823
·
Received April 12, 2011
Report
- Report Number
- 2250051-2011-00072
- Event Type
- Malfunction
- Date Received
- April 12, 2011
- Date of Event
- March 16, 2011
- Report Date
- April 12, 2011
- Manufacturer
- ORTHO CLINICAL DIAGNOSTICS
- Product Code
- KSZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
OCD PERFORMED RETAINED TESTING AND A BATCH RECORD REVIEW. ALL RESULTS WERE SATISFACTORY. (B)(4).
Description of Event or Problem · 1
CUSTOMER REPORTED THAT AN ANTIBODY SCREEN RESULTED 1+ POSITIVE ON A PATIENT SAMPLE WITH NO PREVIOUS HISTORY. TESTING WAS THEN PERFORMED WITH VRA153 AND NO REACTIVITY WAS OBSERVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 0.8% RESOLVE PANEL A | REAGENT RED BLOOD CELLS | KSZ | ORTHO CLINICAL DIAGNOSTICS | VRA153 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |