FDA Adverse Event
Malfunction
Summary report: N
CAPTURE-R READY SCREEN IV
MDR report key: 1896963
·
Received November 11, 2010
Report
- Report Number
- 1034569-2010-00237
- Event Type
- Malfunction
- Date Received
- November 11, 2010
- Date of Event
- October 13, 2010
- Report Date
- November 11, 2010
- Manufacturer
- IMMUCOR
- Product Code
- KSZ
- PMA / PMN Number
- STN 102707
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- MEDICAL TECHNOLOGIST
Narratives
Additional Manufacturer Narrative · 1
CRRS IV LOT K268, WELL FILL IMAGES AND FINAL INTERPRETATION ARE VISUALLY ACCEPTABLE, NEGATIVES LOOK NEGATIVE: (B)(6). CONFIRMED THE REACTIVITY OF THE E ANTIGEN ON RETENTION CAPTURE-R READY-SCREEN (4) (CRRS4) LOTS K264, K268, AND K269 USING MANUAL CAPTURE. CONFIRMED THE (B)(6) OF THE E ANTIGEN ON RETURN CAPTURE-R READY-SCREEN (4) (CRRS4) LOTS K268, AND K269 USING MANUAL CAPTURE. THE EVENT APPEARS TO BE RELATED TO THE NATURE OF THE SAMPLE.
Description of Event or Problem · 1
CUSTOMER REPORTED UNEXPECTED (B)(6) WHEN TESTING A PATIENT SAMPLE WITH CAPTURE-R READY SCREEN (CRRS) IV ON THE GALILEO. THE PATIENT HAD A KNOWN (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CAPTURE-R READY SCREEN IV | REAGENT RED BLOOD CELLS | KSZ | IMMUCOR | K268 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |