BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC.T DIFF 2 ANALYZER

    MDR report key: 1022622 · Received March 31, 2008

    Report

    Report Number
    1061932-2008-00018
    Event Type
    Malfunction
    Date Received
    March 31, 2008
    Date of Event
    March 1, 2008
    Report Date
    March 31, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC IS RUN ONCE A DAY AND WAS RUN BEFORE THE EVENT. QC RESULTS WERE WITHIN RANGE. THE SPECIMENS WERE COLLECTED VIA FINGER STICK AND ONE VIA VENIPUNCTURE. PER CONVERSATION WITH THE CUSTOMER IN 2008, THEY INDICATED THE FINGER STICK SAMPLES MAY NOT HAVE BEEN ADEQUATELY COLLECTED; SOME MAY NOT HAVE BEEN A FULL DRAW IN A MICROTAINER COLLECTION DEVICE. CUSTOMER INDICATED THAT VENIPUNCTURE SAMPLES HAVE NOT DISPLAYED ANY RECOVERY ISSUES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S LAB: THE FSE PERFORMED VERIFICATION OF THE INSTRUMENT, VERIFIED PROPER SAMPLE MIXING AND DRAINING OF THE BATHS. THE FSE CAN QC AND REPRODUCIBILITY WITH NO ERRORS AND BOTH TESTS WERE WITHIN SPECIFICATIONS. PER FSE, CUSTOMER SUSPECTS ERROR IN SAMPLE INTEGRITY AND IS SEEKING TO FURTHER INSTRUCT LAB TECHS IN PROPER FINGER STICK COLLECTION TECHNIQUES. ALTHOUGH SAMPLES COLLECTION TECHNIQUE MAY HAVE CONTRIBUTED TO THIS EVENT, A CLEAR ROOT CAUSE FOR THIS EVENT IS UNKNOWN. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING LOW HEMOGLOBIN (HGB) AND PLATELET (PLT) RESULTS GENERATED BY THE COULTER AC.T DIFF INSTRUMENT. A PATIENT (1) SAMPLE COLLECTED VIA A FINGER STICK WAS TESTED FOR HGB AND PLT AND RESULTS WERE: HGB 4.4G/DL, AND PLT 144X10 TO THE THIRD POWER CELLS/UL. BOTH RESULTS WERE PRINTED WITH AN OPERATOR DEFINED AN "L" FLAG. (L -"LOW RESULT. FOR PATIENT SAMPLES, RESULT IS LOWER THAN THE LOW PATIENT SAMPLE LIMIT"). A SECOND FINGER STICK SAMPLE WAS DRAWN FROM THE PATIENT AND SIMILAR LOW RESULTS WERE OBTAINED. THE RESULTS WERE REPORTED OUT OF THE LAB AND THE CUSTOMER PROVIDED ADDITIONAL FINGER STICK SAMPLES PRINTOUTS WHERE ONE PATIENT WAS DRAWN VIA FINGER STICK AND VENIPUNCTURE AND TWO PATIENT SAMPLES DRAWN TWICE VIA FINGER STICK TECHNIQUE. ALL RESULTS WERE PRINTED WITH AN "X" APERTURE ALERT FLAGS, INDICATING THE OPERATOR FURTHER REVIEW RESULTS. BASED ON INFORMATION PROVIDED, THERE WAS NO AFFECT TO PATIENT OR USER.

    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 NA