BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1972092 · Received January 27, 2011

    Report

    Report Number
    2122870-2011-00130
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    December 28, 2010
    Report Date
    December 29, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PERFORMS LOW LEVEL QC THREE TIMES PER DAY AND A HIGH LEVEL QC TWICE PER DAY. QC RESULTS WERE WITHIN THE ESTABLISHED RANGES PRIOR TO AND AFTER THE EVENT. A SYSTEM CHECK WAS PERFORMED ON (B)(4) 2010 AND THE RESULTS WERE WITHIN THE SPECIFICATIONS. A BCI FIELD SERVICE ENGINEER (FSE) WAS ON SITE ON (B)(4) 2010 AND VERIFIED SUBSTRATE DELIVERY, ASPIRATE PROBES, TRANSDUCER TEMPERATURE, ULTRASONICS AND LUMINOMETER; NO ISSUE WAS NOTED. THE FSE ADJUSTED THE MIXER SPEED AND PERFORMED A DIL-TEST AND ROUTINE SYSTEM CHECK; BOTH MET THE INSTRUMENT SPECIFICATIONS. THE FSE ALSO PERFORMED A HIGH SENSITIVITY SYSTEM CHECK, WHICH FAILED. THE FSE RETURNED ON (B)(4) 2011 AND REPLACED THE ASPIRATE PROBES, THE ASPIRATE PROBE TUBING, THE WASH PUMP SEALS AND THE PRECISION PUMP SEALS. THE FSE THEN PERFORMED ANOTHER HIGH SENSITIVITY SYSTEM CHECK, WHICH FAILED AGAIN. THE FSE REPLACED THE MIXER BELT WHICH APPEARED TO BE DAMAGED. AFTER SOME ADDITIONAL CLEANING OF THE ANALYTICAL MODULE, THE FSE NOTED THAT ALL VERIFICATION TESTING PASSED AND THE SYSTEM WAS RETURNED TO OPERATION. ALTHOUGH SOME HARDWARE ISSUES WERE ADDRESSED, A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) IN REGARDS TO AN ERRONEOUSLY ELEVATED TROPONIN (ACCUTNI) RESULT ABOVE THE AMI CUTOFF GENERATED BY ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT. THE RESULT WAS NOT REPORTED OUT OF THE LABORATORY. SUBSEQUENT TESTING ON THE SAME AND AN ALTERNATE INSTRUMENT PRODUCED RESULTS IN THE NORMAL REFERENCE RANGE. THE EFFECT TO THE PATIENT, IF ANY, IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1