BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-ID

    MDR report key: 8253455 · Received January 16, 2019

    Report

    Report Number
    1034569-2019-00021
    Event Type
    Malfunction
    Date Received
    January 16, 2019
    Date of Event
    December 23, 2018
    Report Date
    January 16, 2019
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    UDI-DI
    10888234001140
    PMA / PMN Number
    BL102707/0.0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2018 IMMUCOR TECHNICAL SUPPORT USED A REMOTE ELECTRONIC CONNECTION METHOD TO REVIEW RESULTS FOR THE ISSUE DESCRIBED. THE CAMERA REPORT APPEARED ACCEPTABLE AND NO INSTRUMENT PROBLEM WAS IDENTIFIED. ON (B)(4) 2018, IMMUCOR TESTED SELECTED CELLS FROM RETENTION CAPTURE-R READY-ID LOT ID369 IN MANUAL CAPTURE WITH ANTI-K LOT K012512F. CONTROLS PERFORMED AS EXPECTED AND CELLS 6 AND 8 (K POSITIVE) RESULTED POSITIVE AS EXPECTED. RETENTION PRODUCT PERFORMED AS EXPECTED. NO SAMPLE OR PRODUCT WAS RETURNED TO IMMUCOR FOR EVALUATION. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2018 A CUSTOMER REPORTED THAT THEY RECEIVED UNEXPECTED NEGATIVE REACTIONS WITH CAPTURE-R READY-ID ON AN ECHO V2.0 INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47132 CAPTURE-R READY-ID AUTOMATED BLOOD BANK SYSTEM KSZ IMMUCOR, INC. ID369 10888234001140

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR