FDA Adverse Event
Malfunction
Summary report: N
REAGENT RED BLOOD CELLS
MDR report key: 1841153
·
Received September 22, 2010
Report
- Report Number
- 1034569-2010-00204
- Event Type
- Malfunction
- Date Received
- September 22, 2010
- Date of Event
- August 25, 2010
- Report Date
- September 22, 2010
- Manufacturer
- IMMUCOR, INC.
- Product Code
- KSZ
- PMA / PMN Number
- STN 102707
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- MEDICAL TECHNOLOGIST
Narratives
Additional Manufacturer Narrative · 1
THE ECHO INSTRUMENT AT BOTH SITES GENERATED NEGATIVE RESULTS FOR C POSITIVE CELLS WITH THE CRRS3 AND CRRID ASSAYS. CUSTOMER DID NOT PROVIDE ACCESS TO BLOOD DIRECT SOFTWARE ON THE ECHO. RESULTS FOR TESTING AND MAINTENANCE WERE FAXED. MONTHLY MAINTENANCE AND DECONTAMINATION WERE ALL WITHIN SPECIFICATIONS. THE CUSTOMER DID NOT RETURN SAMPLE (SAMPLE DEPLETED) FOR FURTHER SEROLOGICAL TESTING.
Description of Event or Problem · 1
CUSTOMER REPORTED UNEXPECTED NEGATIVE RESULTS ON A PATIENT WITH A HISTORY OF ANTI-C (AT A DIFFERENT FACILITY - TUORO) WHEN TESTED WITH CAPTURE-R READY SCREEN 3 (CRRS3) AND CAPTURE-R READY-ID (CRRID) ON THE ECHO INSTRUMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REAGENT RED BLOOD CELLS | CAPTURE-R READY SCREEN (3) | KSZ | IMMUCOR, INC. | R102 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR |