BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2182712 · Received July 28, 2011

    Report

    Report Number
    2122870-2011-02541
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    June 28, 2011
    Report Date
    July 2, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER INC. CUSTOMER TECHNICAL SERVICES LED THE CUSTOMER THROUGH INSTRUMENT TROUBLESHOOTING PROCESSES. THE CUSTOMER REPLACING THE PERI PUMP, ASPIRATE AND DISPENSE PROBE TUBING. A PASSING INSTRUMENT SYSTEM CHECK AFTER TROUBLE SHOOTING VERIFIED INSTRUMENT PERFORMANCE. ALTHOUGH THE INSTRUMENT WAS REPAIRED BY THE CUSTOMER DURING TROUBLE SHOOTING PRIOR TO RETURNING IT BACK INTO SERVICE, A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. MDRS ASSOCIATED WITH THIS EVENT: 2122870-2011-02538; 2122870-2011-02539; 2122870-2011-02540; 2122870-2011-02541; 2122870-2011-02542; 2122870-2011-02543; 2122870-2011-02613.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ERRONEOUSLY ELEVATED CARDIAC TROPONIN (ACCUTNI) RESULTS, WITHIN THE RISK STRATIFICATION RANGE, WERE GENERATED ON AN ACCESS 2 IMMUNOASSAY SYSTEM FOR SIX PATIENTS' SAMPLES. THIS REPRESENTS THE ERRONEOUSLY ELEVATED CARDIAC TROPONIN (ACCUTNI) RESULTS, WITHIN THE RISK STRATIFICATION RANGE, ASSOCIATED WITH PATIENT NUMBER FOUR OF SIX, GENERATED ON (B)(6) 2011. REPEAT TESTING OF THE PATIENT'S SAMPLE ULTIMATELY PRODUCED A LOWER RESULT, WITHIN THE NORMAL REFERENCE RANGE OF THE ASSAY, WHICH WAS CONSIDERED VALID. IT IS UNKNOWN WHETHER REPEAT TESTING WAS PERFORMED ON THE SAME INSTRUMENT OR ANOTHER INSTRUMENT, HOWEVER IT IS BELIEVED THAT THE REPEAT RESULTS WERE GENERATED FROM THE SAME INSTRUMENT. THE PATIENT WAS ADMITTED INTO THE HOSPITAL AND LATER TRANSFERRED TO A DIFFERENT CARE FACILITY WHERE THEY UNDERWENT A CARDIAC CATHETERIZATION PROCEDURE GENERATING A "NEGATIVE" RESULT. THE CUSTOMER HAD REPORTED EXPERIENCING INSTRUMENT ACCUTNI QUALITY CONTROL ISSUES PRIOR TO THE GENERATION OF THE INVOLVED PATIENT RESULTS. AN INSTRUMENT SYSTEM CHECK EXECUTED DURING THE TIMEFRAME OF THIS EVENT FAILED TO MEET CUSTOMER ESTABLISHED SPECIFICATIONS. NO PATIENT INFORMATION OR SAMPLE COLLECTION/HANDLING INFORMATION WAS SUPPLIED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R ACCESS ACCUTNI - REAGENT