FDA Adverse Event
Malfunction
Summary report: N
CAPTURE-R READY INDICATOR RED CELLS
MDR report key: 7235327
·
Received February 2, 2018
Report
- Report Number
- 1034569-2018-00027
- Event Type
- Malfunction
- Date Received
- February 2, 2018
- Date of Event
- January 8, 2018
- Report Date
- February 1, 2018
- Manufacturer
- IMMUCOR, INC.
- Product Code
- KSF
- UDI-DI
- 10888234000600
- PMA / PMN Number
- BK020053
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE FULL NUMBER FOR THE PRODUCT IN QUESTION IS BK020053 ((B)(4) 2003). IMMUCOR TECHNICAL SUPPORT USED A REMOTE ELCTRONIC CONNECTION METHOD ON (B)(4) 2018 TO ASSESS THE INSTRUMENT TEST WELL IMAGE IN QUESTION, AND DETERMINED THAT THE INSTRUMENT TEST WELL IMAGES IN QUESTION WERE CONSISTENT WITH THE INSTRUMENT INTERPRETATION.
Description of Event or Problem · 1
ON (B)(6) 2017, AN IMMUCOR EMPLOYEE VISITING A CUSTOMER SITE REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN WHEN USING CAPTURE-R READY INDICATOR RED CELLS ON A GALILEO NEO INSTRUMENT, WHEN TESTED ON (B)(6) 2018.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 79233 | CAPTURE-R READY INDICATOR RED CELLS | ANTIGLOBULIN COATED RED CELLS | KSF | IMMUCOR, INC. | 221010 | 10888234000600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR |