BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN 3

    MDR report key: 5304103 · Received December 16, 2015

    Report

    Report Number
    1034569-2015-00213
    Event Type
    Malfunction
    Date Received
    December 16, 2015
    Date of Event
    November 22, 2015
    Report Date
    December 16, 2015
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102707/0.0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE CUSTOMER'S INSTRUMENT IMAGE RESULT FILES SHOWED: BATCH (B)(4) USING LOTS R676/221505/LISS 211661. SAMPLE (B)(6) CELL 1 AND 3 NEG VISUALLY NEG . CELL 2 ? VISUALLY POS. CTRL WELL REACTED AS EXPECTED. CELL 1 AND 2 D+, CELL 3 D NEG DONOR. THE PI LAB CONFIRMED THE REACTIVITY OF THE D ANTIGEN ON CELL I AND CELL II OF RETENTION CRRS (3), LOT R676, IN MANUAL CAPTURE, USING RETENTION CAPTURE-R READY INDICATOR RED CELL, LOT 221505 WITH RETENTION ANTI-D LOT OD547 (1:1 DILUTION). CONTROLS PERFORMED AS EXPECTED. CELL I AND CELL II EXHIBITED 4+ REACTIVITY AS EXPECTED. CELL III WAS NEGATIVE AS EXPECTED. CONFIRMED THE REACTIVITY OF THE D ANTIGEN ON CELL I AND CELL II OF RETENTION CRRS (3), LOT R676, ON ECHO, USING RETENTION CAPTURE-R READY INDICATOR RED CELL, LOT 221505 WITH RETENTION ANTI-D LOT DL20612 (1:1 DILUTION). CONTROLS PERFORMED AS EXPECTED. CELL I AND CELL II EXHIBITED 4+ REACTIVITY AS EXPECTED. CELL III WAS NEGATIVE AS EXPECTED. RETENTION PRODUCT PERFORMED AS EXPECTED. PERFORMED ANTIBODY ASSAY ON RETURN PLASMA SAMPLE (B)(6) (ANTI-D IDENTIFIED BY CUSTOMER) ON THE ECHO WITH CRRS (3), LOT R676 USING RETENTION CAPTURE-R READY INDICATOR RED CELL, LOT 221505. CONTROLS PERFORMED AS EXPECTED. CELL I AND CELL III EXHIBITED NEG REACTIVITY AND CELL II EXHIBITED EQUIVOCAL REACTIVITY. CELL II IS VISUALLY POSITIVE. RETESTED WITH ANOTHER TUBE USING CRRS (3), LOT R676 USING RETENTION CAPTURE-R READY INDICATOR RED CELL, LOT 221505. RESULTS WERE THE SAME. RETURN SAMPLE DID NOT PERFORM AS EXPECTED ACCORDING TO THE REPORTED ANTIBODY SPECIFICITY FROM THE CUSTOMER. IT IS UNCLEAR WHY CAPTURE R READY SCREEN (3), LOT R676 DID NOT REACT MORE STRONGLY WITH CUSTOMER'S SAMPLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN UNEXPECTED NEGATIVE WITH THE CAPTURE-R READY-SCREEN 3 (CRRS 3) WHEN TESTING A PATIENT SAMPLE ON THE GALILEO ECHO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831204 CAPTURE-R READY-SCREEN 3 REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. R676

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR