BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN (3)

    MDR report key: 5659148 · Received May 17, 2016

    Report

    Report Number
    1034569-2016-00108
    Event Type
    Malfunction
    Date Received
    May 17, 2016
    Date of Event
    April 13, 2016
    Report Date
    May 17, 2016
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    UDI-DI
    10888234001454
    PMA / PMN Number
    102707/5045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMMUCOR PRODUCT INVESTIGATIONS LAB CONFIRMED THE PRESENCE OF THE S ANTIGEN ON CELL1 OF RETENTION CAPTURE-R READY-SCREEN (3), LOTS R727 AND R728, ON THE ECHO, USING RETENTION CAPTURE-R READY INDICATOR RED CELL, LOT 221604 WITH ANTI-S, LOT 622008 (1:32 DILUTION). CONTROLS PERFORMED AS EXPECTED. CELL 1 GAVE A POSITIVE REACTION OF 3+ AND NEGATIVE IN ALL REMAINING WELLS AS EXPECTED. RETENTION PRODUCT PERFORMED AS EXPECTED. THE CUSTOMER'S SUBMITTED SAMPLE ((B)(6)) WAS GROSSLY HEMOLYZED UPON RECEIPT. HOWEVER, TESTING WAS ATTEMPTED ON THE ECHO, USING RETENTION CAPTURE-R READY-SCREEN LOTS, R727 AND R278 AND RETENTION CAPTURE-R READY INDICATOR RED CELL, LOT 221604. CONTROLS PERFORMED AS EXPECTED, ON BOTH PLATES, AND CUSTOMER'S SAMPLE WOULD NOT GENERATE A RESULT DUE TO A "HEMOLYZED OR SAMPLE INFERENCE" ERROR MESSAGE.

    Description of Event or Problem · 1

    ON (B)(6) 2016, IT WAS STATED THAT AN UNEXPECTED NEGATIVE ANTIBODY SCREEN WAS OBTAINED ON A KNOWN S POSITIVE SAMPLE DURING TROUBLESHOOTING ON GALILEO ECHO M00402.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314829 CAPTURE-R READY-SCREEN (3) REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. R727 10888234001454

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR