BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACT DIFF 2

    MDR report key: 2070009 · Received April 26, 2011

    Report

    Report Number
    1061932-2011-00297
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Date of Event
    March 30, 2011
    Report Date
    March 30, 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

    ONLY SAMPLES COLLECTED IN SARSTEDT 2.7 ML TUBES ARE AFFECTED. VENDOR PART NUMBER FOR THE SARSTEDT TUBE IS (B)(4) AND IS APPROVED FOR USE ON THE ACT DIFF 2 INSTRUMENT. QC IS RUN DAILY AND WAS RUN PRIOR TO THE REPORTED EVENTS AND HAS BEEN WITHIN SPECIFICATION. ON (B)(4) 2011, BCI FIELD SERVICE ENGINEER (FSE) REPLACED TUBE HOLDER ASSEMBLY AND PROBE. INSTRUMENT WAS VALIDATED AND QC WAS WITHIN SPECIFICATIONS. ON (B)(4) 2011, FSE ADJUSTED PROBE MECHANISM AND PROBE WHERE IT CONNECTS TO THE MECHANISM. SARSTEDT TUBES WERE RUN IN BOTH CLOSED VIAL AND OPEN VIAL WITH RESULTS CORRELATING. QC AND INSTRUMENT OPERATION / REPAIR WERE VERIFIED. AT THIS TIME, ROOT CAUSE IS SUSPECTED TO BE THE PROBE PUSHING ON THE BOTTOM OF THE SARSTEDT TUBES ENOUGH TO PARTLY BLOCK ASPIRATION.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT THAT THE ACT DIFF 2 INSTRUMENT GENERATED LOW CBC RESULTS ON PATIENT SAMPLES RUN IN PRIMARY (CLOSED VIAL) MODE WHEN COMPARED TO THE SAME SAMPLE RUN IN SECONDARY (OPEN VIAL) MODE. ERRONEOUS RESULTS ONLY OCCUR WHEN USING SARSTEDT TUBES IN CLOSED VIAL MODE. OPEN MODE RESULTS ARE CONSIDERED CORRECT. ERRONEOUS RESULTS WERE REPORTED OUT OF THE LAB. THERE HAS BEEN NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACT DIFF 2 DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER INC. ACT DIFF 2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1