FDA Adverse Event
Malfunction
Summary report: N
0.8% RESOLVED PANEL A
MDR report key: 1482808
·
Received September 17, 2009
Report
- Report Number
- 2250051-2009-00277
- Event Type
- Malfunction
- Date Received
- September 17, 2009
- Date of Event
- August 26, 2009
- Report Date
- September 17, 2009
- Manufacturer
- ORTHO-CLINICAL DIAGNOSTICS
- Product Code
- KSZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ORTHO CLINICAL DIAGNOSTICS (OCD) PERFORMED RETAINED TESTING. SATISFACTORY RESULTS WERE OBSERVED.
Description of Event or Problem · 1
CUSTOMER REPORTED NO REACTIVITY WITH VRA132 AND A PT WITH A HISTORY OF ANTI-E AND ANTI-KELL. TESTING PERFORMED AT A 15 MINUTE INCUBATION. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (B) (4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 0.8% RESOLVED PANEL A | REAGENT RED BLOOD CELLS | KSZ | ORTHO-CLINICAL DIAGNOSTICS | VRA132 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |