BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL¿ DXL800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2440214 · Received February 6, 2012

    Report

    Report Number
    2122870-2012-00218
    Event Type
    Malfunction
    Date Received
    February 6, 2012
    Date of Event
    January 11, 2012
    Report Date
    January 11, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, 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. THE FIELD SERVICE ENGINEER (FSE) ADJUSTED PIPETTOR ALIGNMENTS, CLEANED OUT THE WASH CAROUSEL, AND REPLACED INSTRUMENT ASPIRATE PROBES TO RESOLVE THE ISSUE. THE FSE PERFORMED A PASSING HIGH SENSITIVITY FOAM SERVICE ASSAY AND A PASSING SYSTEM CHECK WHICH GENERATED RESULTS WITHIN INSTRUMENT SPECIFICATIONS UPON COMPLETION OF THE NECESSARY AND VERIFIED REPAIRS, THE INSTRUMENT WAS RETURNED BACK INTO OPERATION. A CAUSE FOR THIS EVENT COULD NOT BE DETERMINED AND IS CURRENTLY UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERRONEOUS GI MONITOR RESULTS WERE GENERATED ON A UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM FOR FOUR PATIENT SAMPLES. THE CUSTOMER INDICATED EXPERIENCING ASSAY QUALITY CONTROL RESULT FAILURES ON THE DATE OF THIS EVENT AS WELL. THE INITIAL GI MONITOR RESULTS WERE NOT REGARDED AS INCORRECT, THE PATIENT SAMPLES WERE REPEATED AND THE REPEAT RESULTS WERE REGARDED AS ERRONEOUS. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED DATA INDICATED THAT AN ERRONEOUSLY LOW GI MONITOR REPEAT RESULT, WITHIN THE NORMAL RANGE, FOR ONE PATIENT WAS GENERATED; AS PREVIOUS TESTING PRODUCED RESULTS ABOVE THE NORMAL REFERENCE RAGE OF THE ASSAY THAT WERE CONFIRMED TO BE ACCURATE. ADDITIONALLY, A ERRONEOUSLY HIGH REPEAT GI MONITOR RESULT, ABOVE THE NORMAL RANGE, FOR A SECOND PATIENT WAS GENERATED; AS PREVIOUS TESTING PRODUCED RESULTS BELOW THE NORMAL REFERENCE RAGE OF THE ASSAY THAT WERE CONFIRMED TO BE ACCURATE. ERRONEOUSLY ELEVATED REPEAT PATIENT RESULTS FOR THE THIRD AND FOURTH PATIENTS WERE ALSO GENERATED. WHILE THE RESULTS FOR THE THIRD AND FOURTH PATIENT WERE REPRODUCIBLE WITHIN THE NORMAL RANGE OF THE ASSAY, THE REPEAT RESULTS DID NOT REPRODUCE WITHIN LABELED GI MONITOR ASSAY PRECISION CLAIMS. ALL PATIENT SAMPLES WERE REPEATED ON ANOTHER INSTRUMENT WHICH IDENTIFIED THE REPEAT RESULTS AS ERRONEOUS AND CONFIRMED THE INITIAL RESULTS AS VALID. THE SUSPECT REPEAT GI MONITOR RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY AND IT IS CURRENTLY UNKNOWN AS TO WHETHER THERE WAS ANY IMPACT TO THE INVOLVED PATIENTS, OR MODIFICATION TO THEIR TREATMENT REGIMENS BASED UPON THE ERRONEOUS GI MONITOR RESULTS. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED INSTRUMENT PERFORMANCE INFORMATION INDICATED THAT SYSTEM CHECKS PERFORMED ON THE DAY OF THE EVENT FAILED TO MEET INSTRUMENT SPECIFICATIONS. PATIENT DEMOGRAPHIC INFORMATION WAS NOT PROVIDED BY THE CUSTOMER. SAMPLE COLLECTION DEVICE AND CENTRIFUGATION INFORMATION WAS NOT SUPPLIED BY THE CUSTOMER. PATIENT SAMPLES WERE OUT PATIENT SAMPLES THAT ARE CENTRIFUGED AND ALIQUOTED PRIOR TO RECEIPT FOR TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL¿ DXL800 ACCESS® IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE) JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS GI MONITOR REAGENT