BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2689840 · Received August 9, 2012

    Report

    Report Number
    2122870-2012-01672
    Event Type
    Malfunction
    Date Received
    August 9, 2012
    Date of Event
    July 5, 2012
    Report Date
    July 19, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    KXT
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE FOR THIS EVENT THE FIELD SERVICE ENGINEER (FSE) REPLACED THE TRANSDUCER AS "SUSPECT TRANSDUCER ISSUES" WERE NOTED DURING PREVIOUS FSE VISITS. QUALITY CONTROL (QC) WAS PERFORMED FOLLOWING REPLACEMENT OF THE TRANSDUCER AND RESULTS RECOVERED WITHIN THE LABORATORY'S ESTABLISHED RANGES AND CLOSER TO THE MEAN VALUES ASSIGNED TO EACH LEVEL OF QC. A HARDWARE MALFUNCTION IS THE LIKELY CAUSE OF THIS EVENT

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN ERRONEOUS ELEVATED DIGOXIN RESULT ABOVE THE THERAPEUTIC RANGE OF THE ASSAY WAS GENERATED FROM AN ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT'S SAMPLE. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED DATA INDICATED THAT UPON REPEAT TESTING OF THE SAMPLE ON AN ALTERNATE INSTRUMENT, A LOWER DIGOXIN RESULT WAS GENERATED WHICH WAS CONSIDERED VALID. THE ERRONEOUS DIGOXIN RESULT WAS REPORTED OUTSIDE OF THE LABORATORY; HOWEVER, THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY OR CHANGE TO PATIENT MANAGEMENT ASSOCIATED WITH THIS EVENT. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED INSTRUMENT/ASSAY PERFORMANCE DATA, INDICATED THAT LEVEL TWO AND THREE QUALITY CONTROL (QC) RESULTS WERE WITHIN ONE TO TWO STANDARD DEVIATIONS OF THE LABORATORY'S ESTABLISHED RANGE PRIOR TO ANALYSIS OF THE SAMPLE, BUT WERE OUTSIDE THE LABORATORY'S ESTABLISHED RANGE FOLLOWING ANALYSIS OF THE INVOLVED SAMPLE. LEVEL ONE QC RESULTS WERE WITHIN ONE TO TWO STANDARD DEVIATIONS OF THE LABORATORY'S ESTABLISHED RANGE ON THE DATE OF EVENT. CALIBRATIONS PERFORMED PRIOR TO THE EVENT GENERATED PASSING RESULTS WITH ACCEPTABLE PERCENT COEFFICIENTS OF VARIATION. ROUTINE SYSTEM CHECKS PERFORMED PRIOR TO THE EVENT PASSED WITHIN INSTRUMENT SPECIFICATIONS. THE REAGENT AND CALIBRATOR LOTS ASSOCIATED WITH THIS EVENT WERE 1220507 AND 221479 RESPECTIVELY. NO SAMPLE COLLECTION/HANDLING INFORMATION WAS PROVIDED BY THE CUSTOMER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE KXT BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR