FDA Adverse Event
Malfunction
Summary report: N
0.8% RESOLVE PANEL B
MDR report key: 1445035
·
Received August 10, 2009
Report
- Report Number
- 2250051-2009-00228
- Event Type
- Malfunction
- Date Received
- August 10, 2009
- Date of Event
- July 17, 2009
- Report Date
- August 10, 2009
- Manufacturer
- ORTHO CLINICAL DIAGNOSTICS
- Product Code
- MWN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, 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 VRB129 CELL 17 AND TWO PATIENT SAMPLES WITH KNOWN ANTI-E. OTHER E+ CELLS REACTED. CUSTOMER STATES THAT WITHOUT PRIOR PATIENT HISTORY, THEY WOULD NOT HAVE BEEN ABLE TO IDENTIFY THE ANTIBODY. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 0.8% RESOLVE PANEL B | REAGENT RED BLOOD CELLS | MWN | ORTHO CLINICAL DIAGNOSTICS | VRB129 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |