BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY SCREEN (3)

    MDR report key: 2662186 · Received July 19, 2012

    Report

    Report Number
    1034569-2012-00140
    Event Type
    Malfunction
    Date Received
    July 19, 2012
    Date of Event
    June 13, 2012
    Report Date
    July 19, 2012
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    STN 102707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    AN IMMUCOR TECHNICAL SUPPORT SPECIALIST REVIEWED THE IMAGE RESULT FILES. NEGATIVE RESULTS WERE REPORTED FOR ALL CELLS OF THE ANTIBODY SCREENING ASSAY. CELLS 1 AND 2 VISUALLY APPEARED NEGATIVE. CELL 3 VISUALLY APPEARED POSITIVE (1+). A REVIEW OF THE ANTIBODY IDENTIFICATION ASSAY RESULTS SHOWED THAT CELLS 1,2,3,4,5,6,7,8,9,10,11,13 WERE REPORTED AS NEGATIVE. CELLS 1,2,3,4,5,6,7,9,10,11,13 VISUALLY APPEARED NEGATIVE. CELL 8 VISUALLY APPEARED POSITIVE (1+). REPEAT TESTING WAS PERFORMED AND NEGATIVE RESULTS WERE AGAIN OBTAINED. REACTIONS VISUALLY APPEARED NEGATIVE. THE CUSTOMER WAS ADVISED TO REPEAT TESTING WITH A DIFFERENT LOT OF CAPTURE-R READY-SCREEN 3 TEST WELLS. THE SAMPLE RESULTED AS POSITIVE (2+) AS EXPECTED. AN ANTI-K WAS IDENTIFIED. IN-HOUSE TESTING: THE CUSTOMER RETURNED ONE UNOPENED VIAL OF CAPTURE-R READY INDICATOR RED CELLS, LOT 221836 EXP. 2012-06-28, 1 UNOPENED POUCH OF CAPTURE-R READY-SCREEN 3, LOT R218 EXP. 2012-07-03, AND TWO TUBES FROM PATIENT LABELED (B)(6). THE IMMUCOR PRODUCT INVESTIGATION LAB CONFIRMED THE PRESENCE OF THE K ANTIGEN ON RETENTION AND RETURNED CAPTURE-R READY-SCREEN(3) (CRRS3), LOT R218 USING RETENTION AND RETURNED CAPTURE-R READY INDICATOR RED CELL (CRRIRC) LOT 221836 AND ANTI-K, LOT QC#1 (1:256). CONTROLS PERFORMED AS EXPECTED AND ALL REAGENT RED CELLS EXHIBITED THE EXPECTED REACTIVITY. RETENTION AND RETURNED PRODUCTS PERFORMED AS EXPECTED. AN ANTIBODY SCREEN WAS PERFORMED ON THE CUSTOMER'S SUBMITTED SAMPLE ((B)(6)) ON THE ECHO USING RETENTION PRODUCTS CRRS3, LOT R218 AND CRRIRC, LOT 221836. CONTROLS PERFORMED AS EXPECTED. CUSTOMER'S SAMPLE REPORTED AS POSITIVE (1+) ON CELL III AND NEGATIVE ON CELLS I AND II. THE CUSTOMER WAS MADE AWARE OF TECHNICAL COMMUNICATION CC-09-042-02 WHICH ADVISES CUSTOMERS TO VISUALLY INSPECT ALL NEGATIVE ANTIBODY SCREENING AND IDENTIFICATION RESULTS ON THE ECHO PRIOR TO RELEASE OF RESULTS.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT NEGATIVE RESULTS WERE OBTAINED ON THE SCREENING ASSAY ON THE ECHO. VISUALLY, THE RESULTS APPEARED POSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY SCREEN (3) REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. R218

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR