BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN (3)

    MDR report key: 7339299 · Received March 14, 2018

    Report

    Report Number
    1034569-2018-00066
    Event Type
    Malfunction
    Date Received
    March 14, 2018
    Date of Event
    February 14, 2018
    Report Date
    March 14, 2018
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    UDI-DI
    10888234001454
    PMA / PMN Number
    102707/5045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ON 22FEB2018 IMMUCOR PERFORMED AN ANTIBODY SCREEN ON THE ECHO WITH RETURN SAMPLE ((B)(6)) USING RETENTION CAPTURE-R READY SCREEN (3), PLATES LOT R938 AND RETENTION CAPTURE-R INDICATOR CELLS LOT 221028. CONTROLS PERFORMED AS EXPECTED, AND RETURN SAMPLE RESULTED NEGATIVE. IMMUCOR WAS ABLE TO REPRODUCE CUSTOMER'S OBSERVATION WITH SAMPLE 2123916. HOWEVER, OUR INVESTIGATION DID NOT IDENTIFY A PRODUCT DEFICIENCY. THE K ANTIGEN WAS CONFIRMED AS PRESENT AND AVAILABLE FOR ANTIGEN-ANTIBODY REACTIVITY ON CELL 1 OF RETENTION CAPTURE-R READY-SCREEN (3) LOT R938. BASED ON OUR RESULTS, THE TITER OF THE ANTIBODY FOR SAMPLE (B)(6) MAY BE AT OR JUST BELOW THE THRESHOLD OF DETECTION. COMPLAINTS OF POSITIVE REACTIONS BEING INTERPRETED AS NEGATIVE BY THE GALILEO ECHO CAMERA ALGORITHM ARE BEING CORRECTED UNDER DESIGN CONTROL (B)(4). THE ECHO INSTRUMENT IS PERFORMING AS EXPECTED WITH THE EXCEPTION OF THE CAMERA MODULE ABILITY TO APPROPRIATELY IDENTIFY SOME TRUE POSITIVE RESULTS. THE IMMUCOR TECHNICAL COMMUNICATION (B)(4) IS BEING USED BY THE LAB TO VISUALLY CONFIRM ALL NEGATIVE ASSAY EVENTS REPORTED BY THE ECHO INSTRUMENT. (B)(4).

    Description of Event or Problem · 1

    ON 15FEB2018 A CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIVITY FOR A PATIENT SAMPLE ((B)(6)) ON ECHO M01313 USING CAPTURE-R READY-SCREEN (3) LOT R938 WITH CAPTURE-R INDICATOR CELL LOT 221019 (UNDER BATCH 2739) ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183131 CAPTURE-R READY-SCREEN (3) REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. R938 10888234001454

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR