BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2180202 · Received July 27, 2011

    Report

    Report Number
    2122870-2011-02534
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    June 30, 2011
    Report Date
    July 1, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED TO THE SITE FOR THIS EVENT BECAUSE THE CUSTOMER CANCELLED THE SERVICE CALL. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2011 AN ERRONEOUS, HIGH CARDIAC TROPONIN (ACCUTNI) RESULT, WITHIN THE RISK STRATIFICATION RANGE, WAS GENERATED ON AN ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE EMERGENCY ROOM PATIENT. THE INITIAL RESULT WAS REPEATED ON THE SAME INSTRUMENT AN ADDITIONAL FIVE TIMES. THE RESULTS WERE ELEVATED AND WITHIN THE RISK STRATIFICATION RANGE FOR FOUR RESULTS, AND WITHIN THE NORMAL REFERENCE RANGE FOR ONE RESULT. THE SAMPLE WAS SUBSEQUENTLY TESTED AT A DIFFERENT SITE, WHICH PRODUCED A RESULT WITHIN THE NORMAL REFERENCE RANGE, WHICH WAS CONSIDERED VALID. NO ERRONEOUS ACCUTNI RESULT WERE REPORTED OUTSIDE THE LABORATORY, HOWEVER, THE PATIENT TREATMENT WAS AFFECTED VIA AN EXTENDED PATIENT STAY IN THE HOSPITAL EMERGENCY ROOM AWAITING A VALID RESULT. THE CUSTOMER DID NOT RECEIVE ANY FURTHER REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT. INSTRUMENT ACCUTNI QUALITY CONTROL RESULTS RECOVERED WITHIN THE CUSTOMER'S ESTABLISHED RANGES DURING THE TIMEFRAME OF THIS EVENT. SYSTEM CHECK RESULTS GENERATED PRIOR TO THE EVENT MET ESTABLISHED SPECIFICATIONS. THE SAMPLE WAS COLLECTED IN A LITHIUM HEPARIN PLASMA TUBE.

    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 ACCESS ACCUTNI - REAGENT