BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN (3)

    MDR report key: 2550326 · Received April 26, 2012

    Report

    Report Number
    1034569-2012-00077
    Event Type
    Malfunction
    Date Received
    April 26, 2012
    Date of Event
    March 29, 2012
    Report Date
    April 26, 2012
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    STN 102707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMAGE RESULT FILES WERE REVIEWED BY AN IMMUCOR TECHNICAL SUPPORT SPECIALIST. REVIEW OF FILES SHOWED AN ACCEPTABLE CAMERA REPORT AND NO ERRORS AT TIMES OF TESTING. IN CRRS3 LOT R196 BOTH TIMES THE SAMPLE WAS TESTED ON THE ECHO WELL 2 (E HOMOZYGOUS) WAS NEGATIVE WITH A REACTION SCORE OF 0, VISUALLY NEGATIVE. THE SECOND RUN OF THIS LOT GAVE EQUIVOCAL REACTIONS IN WELL 1 AND 3, BOTH E NEGATIVE, WELL 2 WHICH IS E POSITIVE RESULTED NEGATIVE. IN CRRID LOT ID (B)(4) WELLS 3 AND 6 ARE E POSITIVE, 3 HOMOZYGOUS, 6 HETEROZYGOUS. BOTH GAVE EQUIVOCAL REACTIONS WITH REACTION SCORES OF 8, VISUALLY POSITIVE. IN ADDITION WELLS 1 AND 2 WERE POSITIVE (1+), WELLS 9 AND 14 EQUIVOCAL, AND WELL 13 WAS POSITIVE (2+). VISUALLY ALL APPEAR AS REPORTED BY THE ECHO. NO CLINICALLY SIGNIFICANT ANTIBODY IDENTIFIED. THE CUSTOMER WAS REFERRED TO THE LIMITATION SECTION OF THE PACKAGE INSERT WHICH STATES: "NEGATIVE REACTIONS WILL BE OBTAINED IF THE TEST SPECIMEN CONTAINS ANTIBODIES PRESENT IN CONCENTRATION TOO LOW TO BE DETECTED BY THE TEST METHODS EMPLOYED. INSERT CODE (B)(4) REV 6/06." ADVISED CUSTOMER THAT DUE TO WEAK REACTIVITY IN TUBE AND CAPTURE-R READY-ID, WE ARE UNABLE RULE OUT A LOW TITER ANTIBODY. NO FURTHER ACTION REQUIRED. THE INSTRUMENT IS OPERATING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED OBTAINING UNEXPECTED NEGATIVE REACTIONS WITH CAPTURE-R READY-SCREEN 3, LOT R196, FOR A PATIENT WITH A HISTORY OF ANTI-E. EQUIVOCAL TO POSITIVE (2+) REACTIONS WERE OBTAINED WITH SOME TEST WELLS WITH CAPTURE-R READY-ID, (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY-SCREEN (3) REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. R196

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR