BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN 3

    MDR report key: 5199014 · Received November 3, 2015

    Report

    Report Number
    1034569-2015-00166
    Event Type
    Malfunction
    Date Received
    November 3, 2015
    Date of Event
    October 7, 2015
    Report Date
    November 3, 2015
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102707/5045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    SEROLOGICAL EVALUATION THE SCREEN ASSAY WAS PERFORMED ON ECHO (B)(4) USING RETURNED STRIPES OF CRRS (3) PLATES LOT E178 AND A RETENTION VIAL OF CRRIC LOT 221493 WITH THE RECEIVED CUSTOMER SAMPLE. THE WBCORQC WAS PASSED AS EXPECTED. THE SAMPLE REACTED NEGATIVE. THE SCREEN ASSAY WAS PERFORMED ON ECHO (B)(4) USING RETURNED STRIPES OF CRRS (3) PLATES LOT E178 AND A RETENTION VIAL OF CRRIC LOT 221493 WITH A KNOWN ANTI-D POSITIVE SAMPLE. THE REACTION PATTERN IS DESCRIBED IN THE FOLLOWING: CELL 1: 4+ POSITIVE. CELL 2: 4+ POSITIVE. CELL 3: NEGATIVE. THE SCREEN ASSAY WAS PERFORMED ON ECHO (B)(4) USING RETURNED STRIPES OF CRRS (3) PLATES LOT E182 AND A RETENTION VIAL OF CRRIC LOT 221493 WITH THE RECEIVED CUSTOMER SAMPLE. THE WBCORQC WAS PASSED AS EXPECTED. THE REACTION PATTERN OF THE CUSTOMER SAMPLE IS DESCRIBED IN THE FOLLOWING: CELL 1: 1+ POSITIVE. CELL 2: 2+ POSITIVE. CELL 3: NEGATIVE. A MANUAL TUBE TESTING WAS PERFORMED USING THE CUSTOMER SAMPLE AND PANOSCREEN LOT 39336. AFTER ADDITION OF AHG, THE FOLLOWING REACTION PATTERN WAS RECEIVED: CELL 1: +/- (VERY WEAK). CELL 2: NEGATIVE. CELL 3: NEGATIVE. THE RETENTION TESTING WITH A KNOWN ANTI-D POSITIVE SAMPLE DID NOT IDENTIFY A PRODUCT DEFICIENCY. THE ISSUE SEEMS TO BE SAMPLE RELATED AS THE MANUAL TUBE TESTING DID NOT IDENTIFY THE ANTI-D EITHER. THE CUSTOMER COULD NOT TELL IF THE PREGNANT WOMAN RECEIVED RH IMMUNE GLOBULIN. MOREOVER THE BLOOD GROUP OF THE PATIENT WAS UNKNOWN.

    Description of Event or Problem · 1

    CUSTOMER REPORTS UNEXPECTED NEGATIVE REACTIVITY WHEN TESTING A PATIENT SAMPLE WITH CAPTURE-R READY-SCREEN 3 (CRRS 3) ON THE GALILEO ECHO INSTRUMENT. THE SAMPLE CONTAINED AN ANTI-D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728908 CAPTURE-R READY-SCREEN 3 REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. E173

    Patients

    Seq Age Sex Outcome Treatment
    1