BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2312001 · Received October 27, 2011

    Report

    Report Number
    2122870-2011-04847
    Event Type
    Malfunction
    Date Received
    October 27, 2011
    Date of Event
    September 29, 2011
    Report Date
    October 4, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED FOR THIS EVENT AS THE CUSTOMER REPORTED THAT THEIR BIOMEDICAL ENGINEER WOULD PROVIDE INSTRUMENT HARDWARE VERIFICATION. THERE WERE NO REPORTS OF THE REPAIRS, IF ANY, PERFORMED ON THE INSTRUMENT BY THE CUSTOMER'S BIOMEDICAL ENGINEER, HOWEVER, FOR THE PURPOSE OF THIS REPORT AN INSTRUMENT MALFUNCTION WILL BE ASSUMED. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED FOR THIS EVENT TO DATE. ASSOCIATED MDRS: 2122870-2011-04846, 2122870-2011-05026, 2122870-2011-04943, 2122870-2011-04942, 2122870-2011-04847.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ERRONEOUS/IMPRECISE HUMAN CHORIONIC GONADOTROPIN (BHCG), CARDIAC TROPONIN (ACCUTNI) AND CREATINE KINASE-MB ISOENZYME (CK-MB) RESULTS WERE GENERATED ON AN ACCESS 2 IMMUNOASSAY SYSTEM FOR MULTIPLE PATIENT SAMPLES. THIS IS REPORT TWO OF FIVE AND REPRESENTS AN ERRONEOUSLY LOW, AND IMPRECISE BHCG RESULTS GENERATED FOR ONE PATIENT ON (B)(6) 2011. BECKMAN COULTER INC. ASSESSMENT OF THE CUSTOMER SUPPLIED DATA INDICATED THAT THE INITIAL PATIENT RESULT WAS ABOVE THE NORMAL REFERENCE RANGE. THIS INITIAL ERRONEOUSLY LOW RESULT WAS REPORTED OUTSIDE OF THE LABORATORY HOWEVER THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. SUBSEQUENTLY, THE PATIENT SAMPLE WAS REPEATED ON THE SAME INSTRUMENT IN DILUTED AND UNDILUTED FORM. THE REPEAT RESULTS WERE HIGHER AND IN THE SAME GESTATIONAL CATEGORY BUT OUTSIDE OF LABELED ASSAY PRECISION CLAIMS. THE PATIENT WAS ALSO RE-DRAWN AND THE SAMPLE WAS TESTED ON THE SAME INSTRUMENT. THE CUSTOMER DID NOT PROVIDE ANY REPORTS THAT THEY WERE QUESTIONING THE REDRAWN RESULTS AS THE INITIAL RESULT WAS REPRODUCIBLE AND FELL WITHIN THE SAME CLINICAL CATEGORY. NO PATIENT DEMOGRAPHIC INFORMATION OR SAMPLE COLLECTION/HANDLING INFORMATION WAS PROVIDED BY THE CUSTOMER. THE INSTRUMENT BHCG QUALITY CONTROL RESULTS RECOVERED WITHIN CUSTOMER SPECIFICATION ON THE DATE OF THE EVENT AND SYSTEM CHECKS PERFORMED PRIOR TO THE EVENT PASSED WITHIN INSTRUMENT SPECIFICATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS TOTAL SSHCG REAGENT