FDA Adverse Event
Injury
Summary report: N
2250051-2007-00625
MDR report key: 957582
·
Received November 7, 2007
Report
- Report Number
- 2250051-2007-00625
- Event Type
- Injury
- Date Received
- November 7, 2007
- Product Code
- KSZ
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER RETESTED THE PRETRANSFUSION SAMPLES AND REACTIVITY WAS OBERVED WITH VSS129. UNITS TRANSFUSED WERE POSITIVE FOR THE CORRESPONDING ANTIBODIES. ORTHO-CLINICAL DIAGNOSTICS (OCD) QA PERFORMED RETAIN TESTING OF VSS129 TO CONFIRM THE REACTIVITY OF THE C, -E, -S AND -K ANTIGENS. RESULTS WERE SATISFACTORY. THE POTENTIAL MALFUNCTION OF THE DEVICE WAS NOT CONFIRMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KSZ |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |