BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COULTER AC*T DIFF HEMATOLOGY ANALYZER

    MDR report key: 3320500 · Received August 30, 2013

    Report

    Report Number
    1061932-2013-01879
    Event Type
    Injury
    Date Received
    August 30, 2013
    Date of Event
    August 7, 2013
    Report Date
    August 8, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES ARE COLLECTED IN VACUTAINER EDTA TUBES. METHOD OF ANALYSIS AND CENTRIFUGATION INFORMATION WAS NOT PROVIDED BY THE CUSTOMER. BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THE FSE INSPECTED THE INSTRUMENT AND COULD NOT FIND ANY OBVIOUS ISSUES WITH THE INSTRUMENT. AS PREVENTATIVE MAINTENANCE THE FSE REPLACED FILTERS, PUMP TUBING AND CHECK VALVES, CLEANED THE VACUUM CHAMBER AND VERIFIED THE INSTRUMENT. TUBING SPECIFIC INFORMATION HAS NOT BEEN PROVIDED. THE FSE DID STATE THE LABORATORY'S HGB RECOVERY ON THEIR CURRENT LOT OF CONTROLS SHOWED A LOW BIAS AND RECOMMENDED THAT THE LABORATORY ESTABLISH ITS OWN MEAN BETWEEN THE ACT DIFF AND THE SYSMEX ANALYZER. THE FAILURE MODE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. MDR 1061932-2013-01886 IS RELATED TO THIS EVENT AND DOCUMENTS PATIENT # 2 OF THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) REPORTING THAT THE COULTER AC*T DIFFERENTIAL HEMATOLOGY ANALYZER RECOVERED ERRONEOUSLY LOW HEMOGLOBIN (HGB) AND HEMATOCRIT (HCT) ON TWO (2) PATIENT SAMPLES. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY FOR BOTH PATIENTS. BOTH PATIENT SAMPLES WERE RE-RUN AT THE REFERENCE LABORATORY ON THE SYSMEX PRODUCING HIGHER HGB AND HCT RESULTS. THE ORIGINAL LOW RESULTS WERE REPORTED TO THE PHYSICIAN. THE PHYSICIAN ADMITTED BOTH PATIENTS TO THE HOSPITAL FOR A BLOOD TRANSFUSION. THIS REPORT DOCUMENTS ONE (1) OF THE TWO (2) PATIENTS (PATIENT #1) INVOLVED IN THIS EVENT. THE HOSPITAL THEN RE-DREW AND RE-TESTED THE PATIENT'S SAMPLE BEFORE BEING TRANSFUSED AND OBTAINED A HIGHER HGB RESULT YIELDING ABOVE 9.0 G/DL. THE PATIENT WAS NO LONGER TRANSFUSED BASED ON THE HIGHER RESULT. THERE IS NO REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED TO OR CONNECTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429554 COULTER AC*T DIFF HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER AC*T DIFF NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization