BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-ID

    MDR report key: 8268760 · Received January 22, 2019

    Report

    Report Number
    1034569-2019-00033
    Event Type
    Malfunction
    Date Received
    January 22, 2019
    Date of Event
    December 23, 2018
    Report Date
    January 16, 2019
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    UDI-DI
    10888234001188
    PMA / PMN Number
    BL102707/0.0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2019 IMMUCOR TECHNICAL SUPPORT USED A REMOTE ELECTRONIC CONNECTION METHOD TO REVIEW RESULTS FOR THE ISSUE DESCRIBED. THE ERRORS WERE NOTED AND NO INSTRUMENT PROBLEM WAS IDENTIFIED. ON JANUARY 3, 2019 IMMUCOR PERFORMED RETENTION TESTING WITH CAPTURE-R READY-ID LOT ID369 AND RETENTION VIAL OF CAPTURE-R INDICATOR CELL LOT 221230 WITH ONE ANTI E-POSITIVE AND ONE ANTI E-NEGATIVE IN-HOUSE SAMPLE. BOTH SAMPLES REACTED AS EXPECTED. ANTI E-POSITIVE SAMPLE REACTED POSITIVE WITH CELLS 1, 3, 6 AND 14 AS EXPECTED. ANTI E-NEGATIVE SAMPLE REACTED NEGATIVE WITH ALL CELLS. ON JANUARY 3, 2019 AN IMMUCOR SERVICE TECHNICIAN EXAMINED THE ECHO V2.0 INSTRUMENT SERIAL NUMBER (B)(4) AT THE CUSTOMER SITE. THE TECHNICIAN PERFORMED UNEXPECTED REACTION CHECKLIST AND CLEANED PROBE RINSE STATION PROACTIVELY; INSTRUMENT WAS FOUND TO BE IN SPECS FOR ALL MODULES AND RELEASED TO CUSTOMER FOR USE. NO SAMPLE OR PRODUCT WAS RETURNED TO IMMUCOR FOR EVALUATION. THE IMMUCOR INTERNAL REPORT RECORD NUMBER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2019 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
    59138 CAPTURE-R READY-ID AUTOMATED BLOOD BANK SYSTEM KSZ IMMUCOR, INC. ID369 10888234001188

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR