BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC*T DIFF 2 ANALYZER

    MDR report key: 2132165 · Received June 17, 2011

    Report

    Report Number
    1061932-2011-00701
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 31, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE COLLECTED IN NEW SARSTEDT MONOVETTE EDTA 2.6ML TUBES, WHICH HAVE NOT BEEN APPROVED FOR USE ON THE COULTER AC T DIFF 2 ANALYZER. QC WAS RUN BEFORE AND AFTER EACH INCIDENT WITHIN RANGE AND INSTRUMENT IS CURRENTLY PERFORMING WITHIN QC SPECIFICATION. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011 FOR THIS EVENT. THE FSE INSPECTED THE INSTRUMENT, ADJUSTED THE PROBE ALIGNMENT, VERIFIED THE VACUUM AND CLEANED THE BATHS. QC WAS PERFORMED AND REVIEWED, WHICH ALL LEVELS RESULTED WITHIN SPECIFICATION. A STARTUP AND REPRODUCIBILITY WAS ALSO PERFORMED BY THE FSE, WHICH PASSED. THE ROOT CAUSE FOR THE LOWER PLT, RBC AND HIGHER MCV RESULTS IS UNKNOWN; HOWEVER, THE CUSTOMER IS USING A COLLECTION DEVICE THAT HAS NOT BEEN APPROVED FOR USE ON THE ACT DIFF 2 INSTRUMENT WHICH COULD BE THE CAUSE OF THE ERRONEOUS RESULTS. PER LABELING, BECKMAN COULTER NEITHER RECOMMENDS THE USE OF ONE SAMPLE TUBE IN PREFERENCE TO ANOTHER NOR GUARANTEES THE ACCEPTABILITY OF THE SAMPLE TUBE TO PRODUCE QUALITY RESULTS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE COULTER AC T DIFF 2 ANALYZER GENERATED ERRONEOUSLY LOW PLATELET (PLT) RESULT ON ONE (1) PATIENT, WITHOUT AN INSTRUMENT GENERATED FLAG WHEN COMPARED TO THE RERUN RESULT ON AN ALTERNATE REFERENCE INSTRUMENT. IN ADDITION TO THE ERRONEOUS PLT RESULT, THE INSTRUMENT ALSO GENERATED A LOWER RED BLOOD COUNT (RBC) RESULT AND A HIGHER MEAN CELL VOLUME (MCV) RESULT WHEN COMPARED TO THE REFERENCE INSTRUMENT. THE RESULTS WERE REPORTED OUT OF THE LABORATORY AND SOME PATIENTS, INVOLVED IN THIS EVENT, WERE REFERRED TO AN ONCOLOGY PHYSICIAN WHERE IT WAS DETERMINED THE PATIENTS WERE FINE AND NO ADDITIONAL TREATMENT WAS PERFORMED. IT IS UNKNOWN WHETHER THIS PATIENT WAS REFERRED TO THE ONCOLOGIST. ADDITIONAL PATIENTS RECORDED ON DIFFERENT DATES FOR THIS SIMILAR EVENT ARE REPORTED IN THE FOLLOWING MDRS: 1061932-2011-00700, 1061932-2011-00702, 1061932-2011-00703.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER AC*T DIFF 2 ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER, INC. AC*T DIFF 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1