FDA Adverse Event
Malfunction
Summary report: N
0.8% RESOLVE PANEL A
MDR report key: 2491774
·
Received March 14, 2012
Report
- Report Number
- 2250051-2012-00041
- Event Type
- Malfunction
- Date Received
- March 14, 2012
- Date of Event
- February 28, 2012
- Report Date
- March 14, 2012
- Manufacturer
- ORTHO CLINICAL DIAGNOSTICS
- Product Code
- KSZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
OCD PERFORMED RETAINED TESTING AND A BATCH RECORD REVIEW. SATISFACTORY RESULTS WERE OBSERVED. (B)(4).
Description of Event or Problem · 1
CUSTOMER REPORTED THAT A PATIENT SAMPLE WITH A POSITIVE ANTIBODY SCREEN DID NOT REACT WITH VRA165 CELL 4. ALL OTHER D+ CELLS REACTED 1-2+. PATIENT HAD A HISTORY OF ANTI-D. SAMPLE WAS RETESTED AND NO REACTIVITY WAS OBSERVED WITH CELL 4. PATIENT DID NOT REQUIRE ANY TRANSFUSIONS. CUSTOMER STATED THAT QC WAS ACCEPTABLE. CUSTOMER STATED THAT CELL 4 WAS TESTED WITH KNOWN ANTI-D QC MATERIAL AND A 2+ POSITIVE REACTION 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 | VRA165 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |