FDA Adverse Event
Malfunction
Summary report: N
CAPTURE-R READY INDICATOR RED CELLS
MDR report key: 5897274
·
Received August 23, 2016
Report
- Report Number
- 1034569-2016-00216
- Event Type
- Malfunction
- Date Received
- August 23, 2016
- Date of Event
- August 3, 2016
- Report Date
- August 23, 2016
- Manufacturer
- IMMUCOR, INC.
- Product Code
- KSF
- UDI-DI
- 10888234000600
- PMA / PMN Number
- BK020053
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- MEDICAL TECHNOLOGIST
Narratives
Additional Manufacturer Narrative · 1
THE FULL NUMBER FOR THE PRODUCT IN QUESTION IS BK020053 (1/27/2003). IMMUCOR TECHNICAL SUPPORT USED A REMOTE ELECTRONIC CONNECTION METHOD TO ASSESS TEST WELLS ON THE TESTING INSTRUMENT ON 03AUG2016. IMMUCOR TECHNICAL SUPPORT SUBSEQUENTLY DETERMINED THAT ALL OF THE UNEXPECTED NEGATIVE TEST WELL OUTCOMES WERE VISUALLY POSITIVE. THE IMMUCOR LABORATORY TESTED RETENTION PRODUCT ON 04AUG2016, WHICH PERFORMED AS EXPECTED.
Description of Event or Problem · 1
ON (B)(6) 2016, A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN WHEN USING CAPTURE-R READY INDICATOR RED CELLS ON A GALILEO ECHO INSTRUMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 548899 | CAPTURE-R READY INDICATOR RED CELLS | ANTIGLOBULIN COATED RED CELLS | KSF | IMMUCOR, INC. | 221667 | 10888234000600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR |