FDA Adverse Event
Malfunction
Summary report: N
0.8% RESOLVE PANEL B
MDR report key: 1396255
·
Received May 8, 2009
Report
- Report Number
- 2250051-2009-00142
- Event Type
- Malfunction
- Date Received
- May 8, 2009
- Date of Event
- April 2, 2009
- Report Date
- May 7, 2009
- Manufacturer
- ORTHO-CLINICAL DIAGNOSTICS
- Product Code
- MWN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ORTHO CLINICAL DIAGNOSTICS (OCD) WAS NOT ABLE TO PERFORM RETAINED TESTING DUE TO RECEIPT OF COMPLAINT BEYOND THE EXPIRATION DATE OF THE PRODUCT.
Description of Event or Problem · 1
CUSTOMER STATES THAT A PT WITH A HISTORY OF ANTI-E DID NOT REACT WITH VRB125, EXP 04/07/09. NO REACTIVITY WAS OBSERVED WITH CELLS 15 AND 17. A 1+ REACTION WAS OBSERVED WITH THE HOMOZYGOUS E CELL DURING THE ANTIBODY SCREEN (LOT NOT AVAILABLE). 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 | VRB125 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |