BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R SELECT

    MDR report key: 5369501 · Received January 15, 2016

    Report

    Report Number
    1034569-2016-00009
    Event Type
    Malfunction
    Date Received
    January 15, 2016
    Date of Event
    December 1, 2015
    Report Date
    January 15, 2016
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK040024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    RECEIVED 1 SAMPLE, SAMPLE ID: (B)(6) AND 1 DONOR SAMPLE, DONOR ID: (B)(6). NO PRODUCT WAS RECEIVED. PI LAB PERFORMED A CROSSMATCH ASSAY USING RETENTION CAPTURE-R SELECT PLATES LOT SC381 AND RETENTION CAPTURE-R INDICATOR CELLS LOT 221522 WITH RETENTION ANTI-JKA LOT 614007-1 AND JKA POSITIVE DONOR (B)(6) AND JKA NEGATIVE DONOR (B)(6). CONTROLS PERFORMED AS EXPECTED AND THE JKA POSITIVE DONOR WAS INCOMPATIBLE AND THE JKA NEGATIVE DONOR WAS COMPATIBLE AS EXPECTED. RETENTION PRODUCT PERFORMED AS EXPECTED. RETURN SAMPLE TESTING: PI LAB PERFORMED A CROSSMATCH ASSAY USING RETENTION CAPTURE-R SELECT PLATES LOT SC381 AND RETENTION CAPTURE-R INDICATOR CELLS LOT 221522 WITH RETENTION ANTI-JKA LOT 614007-1 AND CUSTOMER RETURNED DONOR SAMPLE (B)(6). CONTROLS PERFORMED AS EXPECTED AND DONOR SAMPLE (B)(6) WAS INVALID DUE TO A FLUID TOO LOW ERROR MESSAGE ON THE ECHO. PI LAB PERFORMED A MANUAL CALIBRATED CROSSMATCH ASSAY USING RETENTION CAPTURE-R SELECT PLATES LOT SC381 AND RETENTION CAPTURE-R INDICATOR CELLS LOT 221522 WITH RETENTION ANTI-JKA LOT 614007-1 AND CUSTOMER RETURNED DONOR SAMPLE (B)(6). CONTROLS PERFORMED AS EXPECTED AND DONOR SAMPLE (B)(6) WAS INCOMPATIBLE AS EXPECTED WITH RETENTION ANTI-JKA LOT 614007-1. RETURNED DONOR SAMPLE PERFORMED AS EXPECTED. PI LAB PERFORMED A CROSSMATCH ASSAY USING RETENTION CAPTURE-R SELECT PLATES LOT SC381 AND RETENTION CAPTURE-R INDICATOR CELLS LOT 221522 WITH RETENTION JKA POSITIVE DONOR (B)(6)AND CUSTOMER RETURNED PATIENT SAMPLE (B)(6). CONTROLS PERFORMED AS EXPECTED AND PATIENT SAMPLE PATH-(B)(6) WAS INCOMPATIBLE AS EXPECTED. CUSTOMER RETURNED PATIENT SAMPLE PERFORMED AS EXPECTED. PI LAB PERFORMED A MANUAL CALIBRATED CROSSMATCH ASSAY USING RETENTION CAPTURE-R SELECT PLATES LOT SC381 AND RETENTION CAPTURE-R INDICATOR CELLS LOT 221522 WITH CUSTOMER RETURNED PATIENT SAMPLE PATH-(B)(6) AND CUSTOMER RETURNED DONOR SAMPLE (B)(6) . CONTROLS PERFORMED AS EXPECTED AND DONOR SAMPLE (B)(6) AND CUSTOMER RETURNED PATIENT SAMPLE WAS COMPATIBLE. REPRODUCED CUSTOMERS OBSERVATION. IMMUCOR PRODUCT PERFORMED AS EXPECTED. UNEXPECTED RESULTS MAY BE SAMPLE-RELATED.

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE CUSTOMER REPORTED OBTAINING UNEXPECTED NEGATIVE (COMPATIBLE) RESULTS WHEN USING CAPTURE-R SELECT PLATES, LOT SC381, ON THE GALILEO ECHO INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28886 CAPTURE-R SELECT RED BLOOD CELLS KSZ IMMUCOR, INC. SC381

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR