BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY ID EXTEND II

    MDR report key: 1663849 · Received April 21, 2010

    Report

    Report Number
    1034569-2010-00087
    Event Type
    Malfunction
    Date Received
    April 21, 2010
    Date of Event
    March 18, 2010
    Report Date
    April 14, 2010
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    STN 102707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF RESULT IMAGES: SAMPLE WAS POSITIVE FOR ANTI-FYA AND ANTI-JKB. REVIEW OF THE CRRID EXTEND I PANEL SHOWS: 4+ POSITIVE REACTION WITH CELL 1 (DONOR (B)(6), HOMOZYGOUS FOR FYA, HETEROZYGOUS FOR JKB) VISUALLY THIS REACTION APPEARS POSITIVE; 4+ POSITIVE REACTION WITH CELL 2 (DONOR (B)(6), NEGATIVE FOR FYA, HOMOZYGOUS FOR JKB) VISUALLY THIS REACTION APPEARS POSITIVE; 4+ POSITIVE REACTION WITH CELL 3 (DONOR (B)(6), NEGATIVE FOR FYA, HOMOZYGOUS FOR JKB) VISUALLY THIS REACTION APPEARS POSITIVE; 3+ POSITIVE REACTION WITH CELL 4 (DONOR (B)(6), NEGATIVE FOR FYA, HETEROZYGOUS FOR JKB) VISUALLY THIS REACTION APPEARS POSITIVE; 2+ POSITIVE REACTION WITH CELL 5 (DONOR (B)(6), HOMOZYGOUS FOR FYA, NEGATIVE FOR JKB) VISUALLY THIS REACTION APPEARS POSITIVE; 2+ POSITIVE REACTION WITH CELL 7 (DONOR (B)(6), NEGATIVE FOR FYA, NEGATIVE FOR JKB) VISUALLY THIS REACTION APPEARS POSITIVE; 4+ POSITIVE REACTION WITH CELL 8 (DONOR (B)(6), NEGATIVE FOR FYA, HOMOZYGOUS FOR JKB) VISUALLY THIS REACTION APPEARS POSITIVE; 4+ POSITIVE REACTION WITH CELL 9 (DONOR (B)(6), HOMOZYGOUS FOR FYA, HOMOZYGOUS FOR JKB) VISUALLY THIS REACTION APPEARS POSITIVE; 1+ POSITIVE REACTION WITH CELL 10 (DONOR (B)(6), HOMOZYGOUS FOR FYA, NEGATIVE FOR JKB) VISUALLY THIS REACTION APPEARS POSITIVE; 3+ POSITIVE REACTION WITH CELL 11 (DONOR (B)(6), HOMOZYGOUS FOR FYA, NEGATIVE FOR JKB) VISUALLY THIS REACTION APPEARS POSITIVE; 4+ POSITIVE REACTION WITH CELL 12 (DONOR (B)(6), HETEROZYGOUS FOR FYA, HETEROZYGOUS FOR JKB) VISUALLY THIS REACTION APPEARS POSITIVE; 2+ POSITIVE REACTION WITH CELL 14 (DONOR (B)(6), HETEROZYGOUS FOR FYA, NEGATIVE FOR JKB) VISUALLY THIS REACTION APPEARS POSITIVE. THE POSITIVE AND NEGATIVE CONTROL WELLS APPEAR AS EXPECTED. REVIEW OF THE CRRID EXTEND II PANEL SHOWS: NEW SAMPLE FROM SAME PATIENT. NEGATIVE REACTION WITH CELL 1 (DONOR (B)(6), HOMOZYGOUS FOR FYA, NEGATIVE FOR JKB) VISUALLY THIS REACTION APPEARS POSITIVE BUT WAS INTERPRETED AS NEGATIVE. A LIGHT PINK BACKGROUND IS OBSERVED WITH A SLIGHTLY FUZZY BUTTON (THIS ISSUE IS DOCUMENTED IN ANOTHER CALL); 4+ POSITIVE REACTION WITH CELL 2 (DONOR (B)(6), NEGATIVE FOR FYA, HOMOZYGOUS FOR JKB) VISUALLY THIS REACTION APPEARS POSITIVE; 4+ POSITIVE REACTION WITH CELL 4 (DONOR (B)(6), HOMOZYGOUS FOR FYA , HETEROZYGOUS FOR JKB) VISUALLY THIS REACTION APPEARS POSITIVE; NEGATIVE REACTION WITH CELL 5 (DONOR (B)(6), HETEROZYGOUS FOR FYA, NEGATIVE FOR JKB) VISUALLY THIS REACTION APPEARS POSITIVE; NEGATIVE REACTION WITH CELL 6 (DONOR (B)(6), HETEROZYGOUS FOR FYA, NEGATIVE FOR JKB) VISUALLY THIS REACTION APPEARS NEGATIVE; 4+POSITIVE REACTION WITH CELL 7 (DONOR (B)(6), HETEROZYGOUS FOR FYA, HETEROZYGOUS FOR JKB) VISUALLY THIS REACTION APPEARS POSITIVE; 4+ POSITIVE REACTION WITH CELL 9 (DONOR (B)(6), HOMOZYGOUS FOR FYA, HOMOZYGOUS FOR JKB) VISUALLY THIS REACTION APPEARS POSITIVE; 4+ POSITIVE REACTION WITH CELL 10 (DONOR (B)(6), HOMOZYGOUS FOR FYA, HOMOZYGOUS FOR JKB) VISUALLY THIS REACTION APPEARS POSITIVE; NEGATIVE REACTION WITH CELL 12 (DONOR (B)(6), HETEROZYGOUS FOR FYA, NEGATIVE FOR JKB) VISUALLY THIS REACTION APPEARS NEGATIVE; 3+ POSITIVE REACTION WITH CELL 13 (DONOR (B)(6), NEGATIVE FOR FYA, HETEROZYGOUS FOR JKB) VISUALLY THIS REACTION APPEARS POSITIVE; 4+ POSITIVE REACTION WITH CELL 14 (DONOR (B)(6), HETEROZYGOUS FOR FYA, HOMOZYGOUS FOR JKB) VISUALLY THIS REACTION APPEARS POSITIVE. THE POSITIVE AND NEGATIVE CONTROL WELLS APPEAR AS EXPECTED. COULD NOT RULE OUT A DEVELOPING ANTI-FYA THAT HAS NOT YET CONVERTED TO IGG AND STILL HAS A STRONG IGM COMPONENT. THE EVENT APPEARS TO BE RELATED TO THE NATURE OF THE SAMPLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE RESULTS WHEN TESTING A PATIENT SAMPLE WITH CAPTURE-R READY ID (CRRID) EXTEND II ON THE ECHO. THE SAMPLE RESULTED NEGATIVE FOR ANTI-FYA. THE SAMPLE WAS LATER FOUND TO BE POSITIVE FOR ANTI-FYA AND ANTI-JKB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY ID EXTEND II REAGENT RED BLOOD CELLS KSZ IMMUCOR DN039

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR