FDA Adverse Event
Malfunction
Summary report: N
0.8% RESOLVE PANEL A
MDR report key: 1398202
·
Received May 22, 2009
Report
- Report Number
- 2250051-2009-00152
- Event Type
- Malfunction
- Date Received
- May 22, 2009
- Date of Event
- April 28, 2009
- Report Date
- May 22, 2009
- Manufacturer
- ORTHO-CLINICAL DIAGNOSTICS
- Product Code
- MWN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ORTHO CLINICAL DIAGNOSTICS (OCD) PERFORMED RETAINED TESTING. SATISFACTORY RESULTS WERE OBSERVED. CUSTOMER STATED SAMPLE QUANTITY WAS INSUFFICIENT FOR FURTHER INVESTIGATION.
Description of Event or Problem · 1
CUSTOMER REPORTED NO REACTIVITY WITH VRA127 CELLS 4, 6, 8, AND 11 AND A PATIENT SAMPLE WITH A NEWLY DEVELOPED ANTIBODY. CELLS # 1, 3, 5, 7 REACTED WEAK -1+ POSITIVE. SAMPLE WAS SENT OUT TO A REFERENCE LAB. REFERENCE LAB CONFIRMED ANTI-JKA. METHOD USED AT REFERENCE LAB IS NOT KNOWN. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 0.8% RESOLVE PANEL A | REAGENT RED BLOOD CELLS | MWN | ORTHO-CLINICAL DIAGNOSTICS | VRA127 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |