BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT DIFF 12¿ ANALYZER

    MDR report key: 3022234 · Received March 26, 2013

    Report

    Report Number
    1061932-2013-00505
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 25, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) REVIEWED QUALITY CONTROL (QC) HISTORY AND NOTICED PLATELET HAD BEEN RUNNING BELOW BUT WITHIN QC RANGES. THE FSE PERFORMED APERTURE VOLTAGE AND LATEX GAIN CHECKS; NO ISSUE WAS NOTED. THE FSE PERFORMED COMPLETE BLOOD COUNT (CBC) REPRODUCIBILITY TEST SUCCESSFULLY. NO INSTRUMENT ISSUE WAS OBSERVED. THE FSE INCREASED THE CALIBRATION FACTORS ON THE RED BLOOD CELL (RBC) AND PLATELET AS CALIBRATION ISSUE WAS SUSPECTED. THE FSE VERIFIED SYSTEM STARTUP AND QUALITY CONTROL (QC); ALL RESULTS WERE ACCEPTABLE. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. A DEFINITIVE CAUSE OF THE INCIDENT IS UNKNOWN. ALL RELATED MEDWATCH REPORTS ASSOCIATED WITH THIS INCIDENT: 1061932-2013-00504, 1061932-2013-00505, 1061932-2013-00506, 1061932-2013-00507.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED LOW PLATELET RESULTS ON CONTROLS AND FOUR PATIENTS' SAMPLES, ON SEPARATE DAYS, INVOLVING THE COULTER ACT DIFF 12 ANALYZER. THE CUSTOMER SENT THE PATIENTS' SAMPLES TO A REFERENCE LABORATORY, ANALYZED ON AN ALTERNATE METHODOLOGY, AND HIGHER RESULTS WERE OBTAINED. THE LOW PLATELET RESULTS WERE RELEASED OUT OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN AS THE VALUES DID NOT CORRELATE WITH THE REFERENCE LABORATORY'S RESULTS. THE RESULTS RECEIVED FROM THE REFERENCE LABORATORY WERE CONSIDERED CORRECT. THERE WAS NO REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE CONTROL DATA PROVIDED CONFIRMED VALUES WERE BELOW THE ASSAY MEAN; HOWEVER CONTROL VALUES WERE WITHIN THE CONTROL RANGES FOR ALL THREE LEVELS OF QUALITY CONTROL (QC). A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THIS IS REPORT TWO OF FOUR REFERENCING THE EVENT DATE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124043 COULTER® ACT DIFF 12¿ ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1