FDA Adverse Event
Malfunction
Summary report: N
CAPTURE-R READY INDICATOR RED CELLS
MDR report key: 6090407
·
Received November 9, 2016
Report
- Report Number
- 1034569-2016-00289
- Event Type
- Malfunction
- Date Received
- November 9, 2016
- Date of Event
- August 11, 2016
- Report Date
- November 9, 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
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE FULL NUMBER FOR THE PRODUCT IN QUESTION IS BK020053 (1/27/2003). THE CUSTOMER PHONE EXTENSION NUMBER IS (B)(6). AN IMMUCOR FIELD SERVICE ENGINEER VISITED THE CUSTOMER SITE TO ASSESS THE TESTING INSTRUMENT IN QUESTION ON 11AUG2016, AND DETERMINED THAT THE INSTRUMENT WAS WORKING AS EXPECTED. THE PRODUCT HAD ALREADY EXPIRED AND WAS NOT AVAILABLE FOR AN IMMUCOR LABORATORY SEROLOGICAL INVESTIGATION, THEREFORE A DHR REVIEW WAS DONE WHICH SHOWED THAT ALL SPECIFICATIONS WERE MET.
Description of Event or Problem · 1
ON (B)(6) 2016, AN IMMUCOR FIELD SERVICE EMPLOYEE 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 |
|---|---|---|---|---|---|---|---|
| 742257 | CAPTURE-R READY INDICATOR RED CELLS | ANTIGLOBULIN COATED RED CELLS | KSF | IMMUCOR, INC. | 221675 | 10888234000600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR |