FDA Adverse Event
Malfunction
Summary report: N
CAPTURE-R READY INDICATOR RED CELLS
MDR report key: 5354168
·
Received January 8, 2016
Report
- Report Number
- 1034569-2016-00005
- Event Type
- Malfunction
- Date Received
- January 8, 2016
- Date of Event
- December 1, 2015
- Report Date
- January 8, 2016
- Manufacturer
- IMMUCOR, INC.
- Product Code
- KSZ
- PMA / PMN Number
- BK020053
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- MEDICAL TECHNOLOGIST
Narratives
Additional Manufacturer Narrative · 1
IMPLICATED PRODUCT CAPTURE-R READY INDICATOR RED CELL, LOT 221515, EXPIRED PRIOR TO COMPLAINT BEING REFERRED TO PI. HOWEVER, PRODUCT DETECTED ANTI-D WHEN QC WAS PERFORMED. ON (B)(6) 2015, PI PERFORMED SCREEN ASSAY ON THE ECHO USING RETENTION WBCORQC 2, LOT 233283 WITH RETENTION CAPTURE-R READY-SCREEN (3), LOT R681 AND CAPTURE-R READY INDICATOR RED CELL, LOT 221515. ALL CONTROLS PERFORMED AS EXPECTED AND WBCORQC 2 (CELLS 1 AND 2 WHICH ARE D+ CELLS) RESULTED POSITIVE AS EXPECTED. RETENTION PRODUCT PERFORMED AS EXPECTED.
Description of Event or Problem · 1
ON (B)(6) 2015, THE CUSTOMER STATED THAT AN UNEXPECTED NEGATIVE RESULT WAS OBTAINED WITH AN ANTIBODY SCREEN ON AN ECHO INSTRUMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 12690 | CAPTURE-R READY INDICATOR RED CELLS | ANTI-IGG COATED RED BLOOD CELLS | KSZ | IMMUCOR, INC. | 221515 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR |