BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® AC *T DIFF 2 ANALYZER

    MDR report key: 3150847 · Received June 6, 2013

    Report

    Report Number
    1061932-2013-01090
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 8, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE INSPECTED THE INSTRUMENT, BUT COULD NOT CONFIRM AN ACTIVE LEAK. THE FSE DID OBSERVE A SPIKE ON PLATELET (PLT) HISTOGRAM WHEN RUNNING QUALITY CONTROL (QC) AND FLAGGING ABNORMAL LOW WITH AN ASTERISK. THE SPIKE WAS NOT PRESENT WHEN PROCESSING PATIENT SAMPLES. THE FSE REPLACED BATHS, VACUUM ISOLATOR CHAMBER AND ASSOCIATED TUBING, MADE ADJUSTMENTS TO APERTURE CURRENT AND RE-ESTABLISHED NEW CLOG DETECT CRITERIA. HOWEVER, THE PROBLEM PERSISTED; ABNORMAL LOW CONTROL WAS RECOVERING IN RANGE BUT FLAGGED WITH AN ASTERISK. PER EMAIL FROM THE FSE ON (B)(4) 2013, THE ANALYZER CARD WAS ORDERED AND INSTALLED ON THE INSTRUMENT RESOLVING THE PLT ASTERISK ON THE LOW CONTROL. THE ANALYZER CARD IS THE MAIN ELECTRONIC PRINTED CIRCUIT (PC) CARD IN THE INSTRUMENT. IT CONTROLS ALL THE INPUT/OUTPUT FUNCTIONS AND DATA ANALYSIS. THE FSE COULD NOT CONFIRM AN ACTIVE LEAK. THE FAILURE MODE RELATED TO THE PLT NOISE WAS A FAULTY ANALYZER CARD. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT LESS THAN 1 ML OF BLOODY FLUID LEAKED ONTO THE CAPS OF CONTROL VIALS FROM THE COULTER AC *T DIFF 2 ANALYZER. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER ALSO STATED THE ANALYZER WAS GENERATING AN ASTERISK ON THE PLATELET (PLT) COUNT FOR THE LOW CONTROL ONLY. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT REVIEWED BY THE CUSTOMER. THERE IS AN EXPOSURE CONTROL/RISK MANAGEMENT PLAN IN PLACE AT THE FACILITY. THE OPERATOR WAS WEARING A LABORATORY COAT AND GLOVES AT THE TIME OF THE INCIDENT. THERE WAS NO BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES, AND THE OPERATOR DID NOT SEEK MEDICAL ATTENTION. THERE WAS NO IMPACT TO PATIENT RESULTS. NO DEATH OR INJURY IS ATTRIBUTED TO THIS EVENT AND THERE WAS NO CHANGE TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250566 COULTER® AC *T DIFF 2 ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER ACT DIFF 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1