BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU5800 CLINICAL CHEMISTRY ANALYZER

    MDR report key: 3853586 · Received June 6, 2014

    Report

    Report Number
    9612296-2014-00088
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 18, 2014
    Report Date
    May 13, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K112412
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT AND REPLACED THE INNER SAMPLE PROBE VALVE. THE REAGENT SYRINGE DRIVE ASSEMBLY WAS LUBRICATED DUE TO SYRINGE DISPENSE ERRORS. SYSTEM WAS PRIMED, PERFORMED PHOTOCAL, CALIBRATED AND RAN QUALITY CONTROL (QC) SAMPLES. ALL RESULTS PASSED AND WITHIN ESTABLISHED RANGES. PERFORMANCE VERIFIED TO MEET SPECIFICATION. THIS ISSUE WAS AN ON-GOING ISSUE WITH TWO ADDITIONAL EVENTS REPORTED BY THE CUSTOMER. ON (B)(4) 2014, THE FSE DETERMINED THE CAUSE WAS DUE TO INNER SAMPLE PROBE VALVE FAILURE ALONG WITH MULTIPLE CONSUMABLE PARTS THAT WERE REPLACED AND ALIGNMENTS/ADJUSTMENTS PERFORMED. ON (B)(4) 2014, A FOLLOW-UP CALL WAS COMPLETED WITH THE CUSTOMER. THE LEAD TECH CONFIRMED THE SYSTEM WAS OPERATIONAL AND NO FURTHER ISSUES HAVE BEEN NOTED. THIS MDR IS RELATED TO THE FOLLOWING MDRS FOR THE SAME ISSUE, OCCURRING ON DIFFERENT DATES: 9612296-2014-00086; 9612296-2014-00087.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED ERRONEOUS CALCIUM TEST RESULTS WERE OBTAINED WHEN USING THE AU5800 CLINICAL CHEMISTRY ANALYZER ON (B)(6) 2014. ON (B)(6) 2014, THE CUSTOMER REPORTED THE ISSUE RECURRED. CUSTOMER REQUESTED IMMEDIATE SERVICE WHEN INNER SAMPLE PROBE UP/DOWN ERROR WAS GENERATED. CUSTOMER CONFIRMED NO ERRONEOUS RESULTS WERE REPORTED OUT FOR THIS EVENT. NO AFFECT TO PATIENT TREATMENT. NO DEATH OR INJURIES REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331184 AU5800 CLINICAL CHEMISTRY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER AU5811-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1