BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY ANALYZER

    MDR report key: 3290954 · Received August 15, 2013

    Report

    Report Number
    2122870-2013-00703
    Event Type
    Malfunction
    Date Received
    August 15, 2013
    Date of Event
    July 29, 2013
    Report Date
    July 29, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE EVALUATED THE INSTRUMENT AND OBSERVED AIR COMING FROM THE FLUIDICS MANIFOLD. THE FSE REBUILT THE PRECISION AND WASH PUMPS, AND REPLACED THE PUMP SEALS TO RESOLVE THE ISSUE. THE FSE PRIMED INSTRUMENT FLUIDICS AND NO FURTHER AIR LEAKS WERE OBSERVED. FAILURE MODE OF THE EVENT IS ATTRIBUTED TO HARDWARE; THE FSE REBUILT THE WASH PUMP AND PRECISION PUMP TO RESOLVE THE AIR LEAK.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING MULTIPLE LUTEINIZING HORMONE (ACCESS HLH) AND ESTRADIOL (ACCESS ESTRADIOL) ASSAY RELATED ISSUES INVOLVING THE ACCESS 2 IMMUNOASSAY ANALYZER. THE CUSTOMER STATED THAT THE ESTRADIOL QUALITY CONTROL (QC) RESULTS GAVE NO VALUE READINGS AND THE HLH QC RESULT HAD AN INCREASE OF TEN FOLD AT THE TIME OF THE EVENT. THE CUSTOMER ALSO OBTAINED AN HLH RESULT OF 42.81 MIU/ML AND AN ESTRADIOL RESULT OF 231 PG/ML FOR ONE (1) PATIENT SAMPLE. SUBSEQUENT REPEAT OF THE PATIENT SAMPLE ON THE SAME INSTRUMENT PRODUCED AN HLH RESULT OF 4.9 MIU/ML AND AN ESTRADIOL RESULT OF 468 PG/ML. NO RESULTS WERE REPORTED OUT OF THE LABORATORY AND THERE WAS NO CHANGE OR EFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. THE SAMPLE WAS COLLECTED IN A SERUM SEPARATOR TUBE (SST) AND SPUN AT 3200 RPM FOR TEN MINUTES. ACCESS HLH REAGENT LOT NUMBER 229482, AND ACCESS ESTRADIOL REAGENT LOT NUMBER 230462 WERE USED IN CONJUNCTION WITH THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394150 ACCESS® 2 IMMUNOASSAY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR