BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC*T DIFF 2 ANALYZER

    MDR report key: 1883463 · Received October 26, 2010

    Report

    Report Number
    1061932-2010-00193
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Date of Event
    September 27, 2010
    Report Date
    October 26, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIMENS WERE DRAWN IN 3 ML VACUTAINER TUBES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THIS EVENT. THE FSE DID NOT SEE ANY ISSUES WITH CONTROL RUNS. THE EXACT DATE OF INCIDENTS WERE NOT PROVIDED BY THE CUSTOMER, SO THE FSE CANNOT STATE IF THE INSTRUMENT WAS IN CONTROL RANGES AT TIME OF PATIENT RUNS. THE FSE EMPTIED THE FULL WASTE CONTAINER. THE FSE REPLACED THE EMPTY CLEANING REAGENT AND DILUENT PAK AS LYSE WAS EMPTY. THE FSE ALSO BLEACHED APERTURES (RED BLOOD COUNT AND WHITE BLOOD COUNT). PERFORMED REPRODUCIBILITY WHICH WAS WITHIN LIMITS AND VERIFIED REPAIR PER ESTABLISHED PROCEDURES. RESULTS MEET PUBLISHED PERFORMANCE SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING ERRONEOUSLY LOW HEMOGLOBIN (HGB), MEAN CELL VOLUME (MCV), AND PLATELET (PLT) RESULTS RESPECTIVELY ON 3 SPECIMENS OVER THE LAST 2 WEEKS THAT WERE GENERATED BY THE COULTER AC*T DIFF 2 ANALYZER. THE ERRONEOUS RESULTS WERE REPORTED OUT TO THE PHYSICIAN AND THE THREE PATIENTS WERE REFERRED TO OTHER PHYSICIANS BASED ON THE LOW RESULTS. PATIENT #1 REPORTED A LOW HEMOGLOBIN RESULT AND WAS SENT TO A HEMATOLOGIST. THE HEMOGLOBIN RESULT ON THE SPECIMEN DRAWN AT THE OTHER DOCTOR'S OFFICE WAS NORMAL. PATIENT #2 SPECIMENS HAD LOW MCV RESULTS. THE CBC WAS REPEATED AT ANOTHER LAB WITH NORMAL RESULT WHEN AN IRON WORKUP WAS ORDERED. PATIENT #3 RECOVERED A LOW PLT RESULT OF 60. A CBC REPEATED AT ANOTHER LAB GAVE A PLT COUNT OF 140 WHICH IS CONSISTENT WITH WHERE THE PLT COUNT NORMALLY RUNS. CORRECTED REPORTS WERE AMENDED BY THE REPEATED RESULTS FROM THE REPEATED RESULTS. THERE WAS NO DEATH OR INJURY ASSOCIATED WITH THIS EVENT.

    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 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization