BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN (3)

    MDR report key: 2960556 · Received February 14, 2013

    Report

    Report Number
    1034569-2013-00031
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 11, 2013
    Report Date
    February 13, 2013
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    STN 102707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL REVIEW OF RESULTS FOR TESTING PERFORMED ON (B)(4) 2013 SHOWED THAT REACTIONS APPEARED AS REPORTED BY THE ECHO INSTRUMENT FOR BOTH THE ANTIBODY SCREENING AND IDENTIFICATION ASSAYS. DATA RESULTS WERE NEGATIVE. THE CUSTOMER PERFORMED A CAMERA CALIBRATION. REPEAT TESTING WAS PERFORMED AND NEGATIVE RESULTS WERE AGAIN OBTAINED. THE CUSTOMER PERFORMED REPEAT TESTING WITH A DIFFERENT LOT OF SCREENING CELLS (R276) AND POSITIVE RESULTS WERE OBTAINED WITH CELL 1 (K+). ADDITIONAL SAMPLES WERE DRAWN FROM THE SAME PATIENT ON (B)(6 )2013 AND ALL RESULTED AS POSITIVE WITH CELL 1. THE VISUAL INTERPRETATION AGREES WITH THE ECHO INTERPRETATION. IMMUCOR PRODUCT INVESTIGATIONS (PI) CONFIRMED THE PRESENCE OF THE K ANTIGEN ON RETENTION PRODUCT. TWO OF THE PATIENTS SAMPLES (IDS (B)(6)) WERE PROVIDED FOR INVESTIGATION. THE PI LAB PERFORMED TESTING ON THE ECHO USING RETENTION CRRS3, LOT R267 AND CAPTURE-R READY INDICATOR RED CELLS (CRRIRC), LOT 221921. CONTROLS PERFORMED AS EXPECTED. SAMPLE (B)(4) RESULTED AS NO INTERPRETATION DUE TO EQUIVOCAL REACTIVITY (VISUALLY POSITIVE) ON CELL 2. SAMPLE (B)(6) RESULTED AS NEGATIVE. THE (B)(4) LAB PERFORMED TESTING ON THE ECHO USING RETENTION CRRS3, LOT R261, AND CAPTURE-R READY INDICATOR RED CELLS (CRRIRC), LOT 221923. CONTROLS PERFORMED AS EXPECTED. BOTH SAMPLES RESULTED AS NEGATIVE. THE PI LAB PERFORMED A DATA ASSAY ON LIQUID REAGENT RED CELLS FROM DONOR (B)(6) ON THE ON THE ECHO. THE RESULTS WERE NEGATIVE. (B)(4) LAB PERFORMED A CROSS MATCH ASSAY ON THE RETURNED SAMPLES ON THE ECHO AGAINST LIQUID REAGENT RED CELLS FROM DONOR (B)(6). CONTROLS PERFORMED AS EXPECTED. THE RESULTS WERE POSITIVE (2+) FOR BOTH SAMPLES. TO CHARACTERIZE THE ANTIBODY, THE RETURNED SAMPLES WERE TESTED AGAINST DONOR (B)(6) IN TUBES USING IMMUADD AND MINIMUM TESTING PARAMETERS. THE RESULTS WERE NEGATIVE FOR BOTH SAMPLES. SAMPLE (B)(4) WAS TESTED WITH SELECTED K+ CELLS BY CAPTURE-SELECT ON THE ECHO. ANTI-KELL WAS IDENTIFIED. REACTIVITY WAS 2-3+ WITH THE KELL POSITIVE INTACT RED CELLS. ALL OTHER CLINICALLY SIGNIFICANT ANTIBODIES WERE RULED OUT. THE (B)(4) LAB PERFORMED TESTING ON SAMPLE (B)(4) ON THE ECHO USING RETENTION CRRS3, LOT R276 AND CAPTURE-R READY INDICATOR RED CELLS (CRRIRC), LOT 221923. CONTROLS PERFORMED AS EXPECTED. CELL I, K+, RESULTED AS 3+. THE UNEXPECTED NEGATIVE REACTIVITY APPEARS TO BE RELATED TO THE NATURE OF THE ANTIBODY IN THE SAMPLE.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED OBTAINING AN UNEXPECTED NEGATIVE REACTION WITH CAPTURE-R READY-SCREEN (3), LOT R267, ON THE ECHO INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64925 CAPTURE-R READY-SCREEN (3) REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. R267

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR