BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT DIFF 2 ANALYZER

    MDR report key: 3183219 · Received June 21, 2013

    Report

    Report Number
    1061932-2013-01236
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 29, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE ON (B)(4) 2013. THE FSE INSPECTED THE INSTRUMENT AND DISCOVERED THAT A LINE COMING OFF THE CHECK VALVE FOR THE SWEEP FLOW WAS NOT FULLY SEATED WHICH WAS CORRECTED BY THE FSE. THE FSE PRIMED THE INSTRUMENT AND RAN A STARTUP. THE STARTUP PASSED AND THE FSE ADJUSTED THE TARGET VALUES. THE FSE RAN CONTROLS AND STILL GETTING HIGH PLT'S. THE FSE THEN REPLACED THE SAMPLE PROBE AND PROBE WIPE AND REPEAT THE STARTUP AND CONTROLS; ALL RESULTS PASSED. THE FSE RAN SEVERAL PATIENT SAMPLES FOR COMPARISON WITH THE LH500 ANALYZER AND THE RESULTS OBTAINED CORRELATED. THE FSE SUSPECTED THAT THE PROBE MAY HAVE HAD A CLOT AT SOME POINT. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. FAILURE MODE WAS ATTRIBUTED TO THE SAMPLE PROBE WHICH NEEDED TO BE REPLACED. THE EVENT IS ALSO A USE ERROR; SAMPLE RESULTS WERE PROCESSED DESPITE THE FACT THAT CONTROLS WERE HIGH OUT OF RANGE FOR PLT THE DAY OF THE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT ERRONEOUS PLATELET (PLT) RESULTS WERE OBTAINED ON THREE DIFFERENT PATIENT SAMPLES RUN ON THE COULTER AC¿T DIFF 2 ANALYZER OVER TWO DAYS, COMPARED TO PLT RESULTS OBTAINED FROM THE LH500 INSTRUMENT WHICH WERE CONSIDERED CORRECT. DATA PROVIDED FOR REVIEW INDICATED THAT THE AC¿T DIFF 2 FAILED PLT STARTUP ON THE DAY OF THE EVENT AND THAT THE QUALITY CONTROL (QC) RESULTS WERE HIGH OUT OF RANGE FOR PLT RESULTS ON MULTIPLE LEVELS. THE CUSTOMER RERAN THE STARTUP AND QC MULTIPLE TIMES, UNTIL BOTH EVENTUALLY PASSED, AND THEN PROCEEDED TO RUN PATIENT SAMPLES. PATIENT RESULTS PROVIDED BY THE CUSTOMER SHOWN THAT PLT RESULTS OBTAINED FROM THE ACT DIFF 2 WERE NOT ACCOMPANIED BY THE INSTRUMENT GENERATED SUSPECT MESSAGES, EXCEPT FOR PATIENT 3 FOR WHICH A SINGLE ASTERISK PLT FLAG WAS RECOVERED ON RERUN RESULTS. COMPLETE BLOOD COUNT (CBC) RESULTS OBTAINED ON THE AC¿T DIFF 2 ANALYZER CORRELATED WITH THE CBC RESULTS OBTAINED ON THE LH 500 INSTRUMENT, BUT ONLY PLT RESULTS OBTAINED ON THE LH 500 WERE ACTUALLY REPORTED OUT AS CORRECT. ALTHOUGH ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY, THERE WAS NO DEATH OR EFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. THIS MDR IS TO REPORT RESULTS FOR PATIENT 3, ANALYZED ON AC¿T DIFF 2 INSTRUMENT ON (B)(6) 2013. PATIENT 1, PATIENT 2, AND PATIENT 3 RESULTS TESTED ON (B)(6) 2013 ARE REPORTED IN MDR #: 1061932-2013-01235.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283731 COULTER® ACT DIFF 2 ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER AC T DIFF 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR