BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMAGE® IMMUNOCHEMISTRY SYSTEM

    MDR report key: 2432369 · Received January 30, 2012

    Report

    Report Number
    2050012-2012-00241
    Event Type
    Malfunction
    Date Received
    January 30, 2012
    Date of Event
    January 5, 2012
    Report Date
    January 5, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    OPX
    PMA / PMN Number
    K962294
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE ON (B)(4) 2012 FOR THIS EVENT. ON (B)(4) 2012 THE FIELD SERVICE ENGINEER (FSE) REPLACED THE REAGENT MIXER AND PERFORMED WASH STATION ALIGNMENTS. THE ISSUE REOCCURRED ON (B)(4) 2012, HOWEVER, THE CUSTOMER ONLY NOTED THAT QUALITY CONTROL RESULTS WERE NOT HOLDING PRECISION, NO ADDITIONAL INCORRECT RESULTS WERE GENERATED. SERVICE VISITED ON (B)(4) 2012 AND REBUILT THE VACUUM PUMP. THE FSE REPLACED A BENT REAGENT PROBE AND REPLACED THE HAMILTON VALVE. THE FSE THEM PERFORMED AN OPTICS ALIGNMENTS. UPON COMPLETION OF THE NECESSARY AND VERIFIED REPAIRS, THE INSTRUMENT WAS RETURNED INTO OPERATION. HARDWARE APPEARS TO BE THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT MULTIPLE IMPRECISE CHEMISTRY PATIENT RESULTS WERE GENERATED FROM AN IMMAGE IMMUNOCHEMISTRY SYSTEM ON (B)(4) 2012. THE EXACT NUMBER OF PATIENTS OR CHEMISTRIES INVOLVED IN THIS EVENT IS UNKNOWN. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED DATA INDICATED THE INVOLVEMENT OF ONLY ONE PATIENT'S RESULTS. AN INITIAL ERRONEOUSLY LOW KAPPA LIGHT CHAIN (KAP) RESULT WAS GENERATED FOR THIS PATIENT, WHICH UPON MULTIPLE REPEAT TESTS, GENERATED HIGHER RESULTS WHICH WERE REGARDED AS VALID. AN AMENDED REPORT WAS ISSUED. THE ERRONEOUS KAP RESULT WAS REPORTED OUT OF THE LABORATORY, HOWEVER, THERE WAS NO DEATH, SERIOUS INJURY OR CHANGE TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. MULTIPLE INSTRUMENT CHEMISTRY QUALITY CONTROL (QC) RESULTS WERE OUTSIDE THE CUSTOMER'S ESTABLISHED SPECIFICATION DURING THE TIMEFRAME OF THE EVENT. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED INSTRUMENT CHEMISTRY PERFORMANCE DATA INDICATED THAT CALIBRATION RESULTS DURING THE TIMEFRAME OF THIS EVENT WERE ACCEPTABLE. NO PATIENT INFORMATION OR SAMPLE COLLECTION/HANDLING INFORMATION WAS PROVIDED BY THE CUSTOMER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMAGE® IMMUNOCHEMISTRY SYSTEM NEPHELOMETER, FOR CLINICAL USE OPX BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1