BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT 8/10 ANALYZER

    MDR report key: 3123055 · Received May 21, 2013

    Report

    Report Number
    1061932-2013-00878
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 26, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE INSPECTED THE INSTRUMENT AND FOUND THAT CONNECTING TUBING ON LYSE PICK UP TUBE WAS PARTIALLY LEAKING. THE FSE ALSO NOTED THAT WASTE FITTING WAS BENT AND LOOSE DUE TO THE STRETCHED WASTE LINE. THE FSE REPAIRED THE LYSE PICK UP TUBING, REPLACED THE WASTE FITTING AND RE-ARRANGED THE WASTE LINE. THE FSE TESTED THE ANALYZER, RUN QUALITY CONTROL (QC) AND SAMPLES. THE INSTRUMENT WAS WORKING WITHIN SPECIFICATIONS. AS OF (B)(4) 2013, THERE HAVE BEEN NO FURTHER LEAKS OR HIGH MEAN CORPUSCULAR HEMOGLOBIN CONCENTRATION (MCHC) REPORTED. FAILURE MODE WAS THE CONNECTING TUBING ON LYSE PICK UP TUBE PARTIALLY LEAKING, AND WASTE FITTING WAS BENT AND LOOSE DUE TO THE STRETCHED WASTE LINE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT THEY NOTICED A LEAK UNDER THE COULTER ACT 8/10 ANALYZER ON THE COUNTER. HOWEVER, THE CUSTOMER WAS NOT ABLE TO FIND THE SOURCE OF THE LEAK. THE VOLUME OF THE LEAK WAS APPROXIMATELY 20 CC, AND IT WAS A CLEAR FLUID. THE CUSTOMER ALSO REPORTED THAT THEY RECEIVED A LOW LYSE ERROR AND THEY REPLACED THE REAGENT AND PRIMED THE INSTRUMENT. THE CUSTOMER INDICATED THAT THEY RAN A START UP AND CONTROLS AND OBTAINED VERY HIGH MEAN CORPUSCULAR HEMOGLOBIN CONCENTRATION (MCHC) RESULTS ON QUALITY CONTROL (QC). THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE), CONSISTING OF A LABORATORY COAT, GLOVES, AND GOGGLES WHEN THE LEAK WAS OBSERVED. THERE WAS NO BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. NO ERRONEOUS PATIENT RESULTS WERE GENERATED IN CONNECTION TO THE REPORTED EVENT. THERE WAS NO CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224734 COULTER® ACT 8/10 ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA

    Patients

    Seq Age Sex Outcome Treatment
    1