BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 3093312 · Received May 6, 2013

    Report

    Report Number
    2122870-2013-00428
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 5, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) EXAMINED THE PRECISION PUMP AND VERIFIED PIPETTOR ALIGNMENTS. THE FSE DISCOVERED THE ULTRASONICS VOLTAGE WAS LOW AND THE PIPETTOR PROBE WAS CORRODED AT THE PROBE NUT. THE FSE REPLACED THE PIPETTOR PROBE NUT AND PERFORMED A BASELINE AND DISPLACEMENT VOLTAGE ADJUSTMENTS TO RESOLVE THE ISSUE. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. THE CUSTOMER NOTED THE MICROPARTICLE WELL WAS NOT MIXED AND BEGAN MIXING THE ONBOARD REAGENT PACKS AS A TROUBLESHOOTING MEASURE FOR THE NON-REPRODUCIBLE RESULTS. BECKMAN COULTER CUSTOMER TECHNICAL SUPPORT (CTS) ADVISED THE CUSTOMER THAT MIXING THE REAGENT MAY CAUSE REAGENT TO LEAK WHICH MAY IMPACT ACCURACY OF RESULTS. ALL RELATED MEDWATCH REPORTS ASSOCIATED WITH THIS INCIDENT: 2122870-2013-00425, 2122870-2013-00426, 2122870-2013-00427, 2122870-2013-00428, 2122870-2013-00429, 2122870-2013-00430.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED NON-REPRODUCIBLE PROSTATE-SPECIFIC ANTIGEN (PSA) HYBRITECH (PSA-HYB) RESULTS. THIS IS REPORT FOUR OF SIX.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED NON-REPRODUCIBLE PROSTATE-SPECIFIC ANTIGEN (PSA) HYBRITECH (PSA-HYB) AND TESTOSTERONE RESULTS, FOR MULTIPLE PATIENTS, ON SEPARATE DAYS, INVOLVING THE ACCESS 2 IMMUNOASSAY SYSTEM USED IN CONJUNCTION WITH THE HYBRITECH PSA AND ACCESS TESTOSTERONE ASSAYS AND CALIBRATORS. THE PATIENTS' SAMPLES WERE REANALYZED ON THE SAME INSTRUMENT, FOLLOWING SERVICE ON THE ANALYZER, AND PSA RESULTS, WITHIN THE SAME CLINICAL CATEGORY OR OUTSIDE OF THE PRECISION CLAIMS, WERE OBTAINED. THE CUSTOMER STATED THE INITIAL PSA-HYB AND TESTOSTERONE RESULTS WERE RELEASED OUT OF THE LABORATORY. THERE WAS NO REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED TO OR ASSOCIATED WITH THIS EVENT. THE CUSTOMER STATED QUALITY CONTROL (QC) WAS WITHIN SPECIFICATIONS PRIOR TO AND AFTER THE EVENT. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THIS IS REPORT FOUR OF SIX REFERENCING THE EVENT DATE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196098 ACCESS® 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1