BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN 3

    MDR report key: 5320244 · Received December 22, 2015

    Report

    Report Number
    1034569-2015-00214
    Event Type
    Malfunction
    Date Received
    December 22, 2015
    Date of Event
    November 23, 2015
    Report Date
    December 21, 2015
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102707/0.0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE CAP_R_3 ASSAY WAS PERFORMED ON GALILEO USING RETENTION STRIPES OF CRRS(3) PLATES LOT E182 AND RETENTION VIAL OF CRIC LOT 221516 WITH THE RECEIVED CUSTOMER SAMPLE ((B)(6)) AND A KNOWN ANTI-KELL POSITIVE AND A KNOWN ANTI-KELL NEGATIVE IN-HOUSE SAMPLE. THE KNOWN ANTI-KELL NEGATIVE SAMPLE REACTED NEGATIVE AS EXPECTED. THE REACTION PATTERN OF THE OTHER TWO SAMPLES IS DESCRIBED IN THE FOLLOWING: SAMPLE ID (B)(6): CELL 1: NEGATIVE, CELL 2: 1+ POSITIVE (VALUE: 44.10), CELL 3: NEGATIVE. KNOWN ANTI-KELL POSITIVE IN-HOUSE SAMPLE: CELL 1: NEGATIVE, CELL 2: 4+ POSITIVE (VALUE: 99.00), CELL 3: NEGATIVE. RETENTION PRODUCT PERFORMED AS EXPECTED WITH THE KNOWN ANTI-KELL NEGATIVE AND POSITIVE IN-HOUSE DONOR SAMPLES.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845649 CAPTURE-R READY-SCREEN 3 REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. E182

    Patients

    Seq Age Sex Outcome Treatment
    1