BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY INDICATOR RED CELLS

    MDR report key: 1400908 · Received June 11, 2009

    Report

    Report Number
    1034569-2009-00194
    Event Type
    Malfunction
    Date Received
    June 11, 2009
    Date of Event
    May 15, 2009
    Report Date
    June 5, 2009
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    BK020053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER RETURNED 1 PATIENT SAMPLE (HISTORY OF ANTI-K); IT WAS TESTED BY MANUAL CAPTURE METHOD WITH RETENTION CAPTURE-R READY SCREEN LOT K218 (ALSO USED BY THE CUSTOMER AT THE TIME OF THE EVENT) USING RETENTION CAPTURE-R READY INDICATOR RED CELLS (CRRIC), LOT 221367. CRRIC LOT 221363 EXPIRED BEFORE THE SAMPLE WAS RECEIVED. THE SAMPLE WAS NONREACTIVE. THE SAMPLE EXHIBITED WEAK REACTIVITY WITH 2/3 K+K+ CELLS OF CAPTURE-R READY ID, LOT ID114, ALSO USED BY THE CUSTOMER AT THE TIME OF THE EVENT. THE SAMPLE WAS TESTED BY TUBE HEMAGGLUTINATION TESTS WITH SELECTED K+K-, K-K+, AND K+K+ CELLS FROM RETENTION PANOCELL-20, LOT 12348, USING IMMUADD AS THE POTENTIATOR. A ROOM TEMPERATURE (RT) INCUBATION WAS INCLUDED. RESULTS INDICATED THE SAMPLE'S ANTI-K HAS A SIGNIFICANT IGM COMPONENT. THE PACKAGE INSERT FOR CRRIC INDICATES THAT IGM ANTIBODIES MAY NOT BE DETECTED BY CAPTURE PRODUCTS. THE OTHER SAMPLE WAS NOT RETURNED FOR TESTING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THEY WERE HAVING AN ISSUE WITH THEIR CAPTURE INDICATOR CELLS (CRRIC). THEY MISSED KELL ANTIBODIES ON PATIENT SAMPLES WITH THE MANUAL CAPTURE STATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY INDICATOR RED CELLS ANTI-IGG-COATED INDICATOR RED CELLS KSZ IMMUCOR 221363

    Patients

    Seq Age Sex Outcome Treatment
    1