BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY SREEN I AND II

    MDR report key: 2120081 · Received June 10, 2011

    Report

    Report Number
    1034569-2011-00064
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 13, 2011
    Report Date
    June 10, 2011
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    STN 102707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CRRS I AND II ASSAY WAS PERFORMED ON THE GALILEO USING CUSTOMERS RETURNED SAMPLES. PLASMA 1, 2, 3, 4 AND THE SERUM OF PATIENT (B)(6) AS WELL AS A KNOWN ANTI-K+ PLASMA WERE TESTED. ALL SAMPLES REACTED POSITIVE WITH THE K-ANTIGEN CARRYING CELL 2 AND NEGATIVE WITH CELL 1 AS EXPECTED. TESTING WAS PERFORMED WITH STRIPES OF CRRS (I AND II) LOT W162 AND LOT W161. PLASMA 1, 2, 3 AND 4 AND THE SERUM OF PATIENT (B)(6) REACTED 2+ TO 4+ WITH CELL 2 AND NEGATIVE WITH CELL 1 AS EXPECTED FOR AN ANTI-K POSITIVE SAMPLE. THE KNOWN ANTI-K POSITIVE PLASMA USED AS CONTROL REACTED ALSO AS EXPECTED, 1+ - 2+ WITH CELL 2 AND NEGATIVE WITH CELL 1. THE CRRS I AND II ASSAY WAS PERFORMED ON THE GALILEO USING THE SAME REAGENTS AS PREVIOUS TESTING THIS TIME INCLUDING IN-HOUSE DONOR SAMPLES AS NEGATIVE CONTROLS AND A 1:16 DILUTED ANTI-K REAGENT SERUM AS POSITIVE CONTROL. PLASMA 1, 2, 3, AND 4 AND THE SERUM OF PATIENT (B)(6) REACTED POSITIVE WITH THE K-ANTIGEN CARRYING CELL 2 AND NEGATIVE WITH CELL 1 AS EXPECTED. ALL NEGATIVE DONOR SAMPLES AND THE ANTI-K REAGENT DILUTION 1:16 DISPLAYED THE EXPECTED REACTIVITY AS WELL. THE CUSTOMER ISSUE WAS NOT REPRODUCED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED UNEXPECTED NEGATIVE RESULTS WHEN TESTING A PATIENT SAMPLE WITH AN KNOWN ANTI-K WITH CAPTURE-R READY SCREEN (CRRS) I AND II LOTS W161 AND W162.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY SREEN I AND II REAGENT RED BLOOD CELL KSZ IMMUCOR, INC. W161

    Patients

    Seq Age Sex Outcome Treatment
    1