FDA Adverse Event
Malfunction
Summary report: N
0.8% SELECTOGEN
MDR report key: 1408784
·
Received June 22, 2009
Report
- Report Number
- 2250051-2009-00199
- Event Type
- Malfunction
- Date Received
- June 22, 2009
- Date of Event
- June 10, 2009
- Report Date
- June 22, 2009
- Manufacturer
- ORTHO-CLINICAL DIAGNOSTICS
- Product Code
- MWN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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 STATED THAT A SAMPLE WITH ANTI-E FAILED TO REACT WITH 0.8% SELECTOGEN, VS269. CUSTOMER OBSERVED AN INCOMPATIBLE CROSSMATCH WITH ONE UNIT. ANTI-E WAS IDENTIFIED WITH VRA129. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 0.8% SELECTOGEN | REAGENT RED BLOOD CELLS | MWN | ORTHO-CLINICAL DIAGNOSTICS | VS269 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |