BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN (3)

    MDR report key: 5150180 · Received October 14, 2015

    Report

    Report Number
    1034569-2015-00154
    Event Type
    Malfunction
    Date Received
    October 14, 2015
    Date of Event
    August 24, 2015
    Report Date
    October 14, 2015
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102707/5045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IMMUCOR TECHNICAL SUPPORT USED A REMOTE ELECTRONIC CONNECTION METHOD TO ASSESS THE TEST WELL IMAGES ON THE ECHO: BATCH (B)(4). SAMPLE (B)(4). SCI- NEG RESULT- VISUALLY NEGATIVE. SCII- NEG RESULT- VISUALLY NEGATIVE. SCIII- NEG RESULT- VISUALLY POSITIVE (K+,K+) DONOR (B)(6). CONTROL WELL RESULTED AS EXPECTED. VISUALLY THE SAMPLE THAT RESULTED AS NEGATIVE HAS A VISUALLY POSITIVE APPEARANCE IN THE SCIII WHICH IS K+ HOWEVER IT IS MUCH WEAKER THAN THE 3+ THAT WAS PRODUCED WITH THE SAME SAMPLE USING DIFFERENT LOTS OF REAGENTS PI LAB CONFIRMED THE REACTIVITY OF THE K ANTIGEN ON CELL 3 OF RETENTION CAPTURE-R READY SCREEN (3) PLATES LOT R648 IN MANUAL CAPTURE USING RETENTION CAPTURE-R INDICATOR CELLS LOT 221471 WITH RETENTION ANTI-K LOT QC #1 DILUTED 1:128. CONTROLS PERFORMED AS EXPECTED AND CELL 3 (DONOR (B)(6)) WAS POSITIVE AS EXPECTED. RETENTION PRODUCT PERFORMED AS EXPECTED

    Description of Event or Problem · 1

    A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN WHEN TESTING A PATIENT SAMPLE WITH CAPTURE-R READY-SCREEN 3 (CRRS3) ON A GALILEO ECHO INSTRUMENT. THE PATIENT HAS A HISTORY OF ANTI-K.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681205 CAPTURE-R READY-SCREEN (3) REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. R648

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR