BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY ANALYZER

    MDR report key: 2993388 · Received March 7, 2013

    Report

    Report Number
    2122870-2013-00200
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 10, 2013
    Report Date
    February 14, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: LUMINOMETER DRIFT CORRECTION FACTOR, WASH PUMP LOWER SEAL AND O-RING, WASH VALVE STATOR, WASH VALVE ROTOR, PUMP-TO-MANIFOLD O-RING, HIGH POWER ULTRASONICS VOLTAGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN ISSUE WITH ACCUTNI (TROPONIN I) PERFORMANCE OVER SEVERAL DAYS INVOLVING AN ACCESS 2 IMMUNOASSAY ANALYZER. THE CUSTOMER INDICATED THAT THE ISSUE HAS BEEN ONGOING OVER A PERIOD OF 5 DAYS SINCE (B)(6) 2013. THE CUSTOMER PROVIDED CORRELATION DATA BETWEEN THE QUESTIONED INSTRUMENT AND AN ALTERNATE ACCESS 2 ANALYZER FOR 74 PATIENT SAMPLES. DATA ANALYSIS INDICATED THAT 14 PATIENT SAMPLES WERE ERRONEOUS, IMPRECISE, OR BOTH. THE CUSTOMER INDICATED THAT RESULTS WERE REPORTED OUT OF THE LABORATORY BUT CONFIRMED THAT PATIENT TREATMENT WAS NOT AFFECTED AND NO PATIENTS WERE HARMS AS A CONSEQUENCE OF THE ERRONEOUS RESULTS. THE SAMPLES WERE COLLECTED USING PLASMA SEPARATOR TUBES AND CENTRIFUGED FOR 6 MINUTES AT 5,000 RPM OR 10 MINUTES AT 3,700 RPM. QUALITY CONTROL (QC) RESULTS WERE WITHIN THE LABORATORY'S ESTABLISHED LIMITS ON THE DAY OF THE EVENT; HOWEVER, THE LOW LEVEL QC PERFORMED WORSE THAN THE ALTERNATE ANALYZER. THE CUSTOMER DID NOT REPORT ANY SAMPLE QUALITY ISSUES. THE CUSTOMER PERFORMED A SYSTEM CHECK ON (B)(6) 2013, WHICH PASSED ALL SPECIFICATIONS BUT EXHIBITED HIGH WASHED COEFFICIENT OF VARIATION (%CV) AT 10.74% WHICH WAS NEAR THE UPPER LIMIT OF 12%. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND OBSERVED THAT TWO OF THE THREE ASPIRATE PROBES WERE DIRTY. THE FSE REPLACED ALL THREE ASPIRATE PROBES AND PERISTALTIC PUMP TUBING. THE FSE IDENTIFIED FOAM IN THE WASH PUMP AND VALVE DURING DISPENSE PROBE PRIME AND REPLACED THE WASH PUMP LOWER SEAL AND O-RING, THE WASH PUMP TIMING BELT, THE WASH VALVE STATOR, THE WASH VALVE ROTOR, THE WASH VALVE GASKET, AND THE PUMP-TO-MANIFOLD O-RING. THE FSE ALSO ADJUSTED THE LUMINOMETER DRIFT CORRECTION FACTOR (DCF). THE FSE NOTED THAT THE INCUBATOR BELT WAS TIGHT, THE MIXER PULLEYS WERE BENT AND WOBBLING, AND THE WASH WHEEL BEARINGS WERE DIRTY AND DID NOT HAVE A SMOOTH MOTION; ALL THE PARTS WERE REPLACED TO CORRECT THE ISSUE. THE FSE OBSERVED FOAMING IN THE PARAMAGNETIC PARTICLE AND ADJUSTED THE ULTRASONICS VOLTAGE TO THE CORRECT SPECIFICATION. REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED SPECIFICATIONS. FAILURE MODE IS HARDWARE MALFUNCTION OF ONE, A CONDITIONAL OR ALL OF THE PARTS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97359 ACCESS® 2 IMMUNOASSAY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1