BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO ECHO

    MDR report key: 2211193 · Received August 15, 2011

    Report

    Report Number
    1034569-2011-00113
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 21, 2011
    Report Date
    August 12, 2011
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK 070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF RESULTS: SAMPLE ID (B)(6), CRRS 3 LOT R153: CELL1: 0, VISUAL NEGATIVE BUTTON, HALO OF ADHERENCE; CELL2: 0, VISUAL NEGATIVE BUTTON, HALO OF ADHERENCE; CELL3: 0, VISUALLY NEGATIVE. REPEAT TESTING: CELL1: 8, (RESULTED AS EQUIVOCAL, CUSTOMER EDITED TO NEGATIVE REACTION) VISUALLY HAS NEGATIVE FUZZY BUTTON, WITH ADHERENCE; CELL2: 2, NEGATIVE BUTTON, ADHERENCE AROUND BUTTON; CELL3: 2, NEGATIVE BUTTON, ADHERENCE AROUND BUTTON. A SERVICE CALL WAS MADE. THE INSTRUMENT WAS TESTED AND FOUND TO BE PERFORMING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS ON A PATIENT SAMPLE TESTED WITH CAPTURE-R READY SCREEN (CRRS) 3 ON THE ECHO. THE SAMPLE HAD A KNOWN ANTI-K.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GALILEO ECHO AUTOMATED BLOOD BANK ANALYZER KSZ IMMUCOR, INC. M01067

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR