BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT DIFF 2 ANALYZER

    MDR report key: 3202943 · Received July 2, 2013

    Report

    Report Number
    1061932-2013-01254
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 7, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONTROLS WERE RUN BEFORE THE INCIDENT, BUT NOT AFTER THE EVENT. THE UNIT CURRENTLY IS PERFORMING WITHIN QUALITY CONTROL (QC) SPECIFICATIONS WITH RESPECT TO CONTROLS (ACCURACY) AND REPRODUCIBILITY (PRECISION). THE CUSTOMER REQUESTED SERVICE AND BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE INSPECTED THE ANALYZER AND FOUND BATHS WERE NOT DRAINING. UPON FURTHER INSPECTION, THE FSE DISCOVERED THAT THE PUMP WAS NOT WORKING PROPERLY CAUSING THE BATHS NOT TO DRAIN. THE FSE REPLACED THE WASTE PUMP AND ALSO REMOVED CLOGS IN THE WASTE TUBING AND THIS RESOLVED THE ISSUE. THE FSE PERFORMED SYSTEM VERIFICATION, WHICH PASSED. FAILURE MODE WAS ATTRIBUTED TO AN INADEQUATE DRAINING OF THE BATHS DUE TO A PLUG IN THE WASTE PATHWAY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT ERRONEOUS HEMOGLOBIN (HGB) AND HEMATOCRIT (HCT) RESULTS WERE OBTAINED ON THE FIRST TWO PATIENTS AFTER PROCESSING MORNING CONTROLS ON THE COULTER ACT DIFF 2 ANALYZER. ERRONEOUS RESULTS WERE SUSPECTED BECAUSE THE HEMOGLOBIN/HEMATOCRIT (H/H) RATIO DID NOT CORRELATE. THE EXAMPLE GIVEN WAS 11 HGB WITH A 22 HCT. THE INSTRUMENT PRINTOUTS WERE REQUESTED, BUT WERE NOT PROVIDED BY THE CUSTOMER, THEREFORE FURTHER EVALUATION AND FLAGGING COULD NOT BE ASSESSED. NO ERRONEOUS RESULTS WERE REPORTED OUT THE LABORATORY. THERE WAS NO DEATH, INJURY, OR EFFECT TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302395 COULTER® ACT DIFF 2 ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER AC T DIFF 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1