BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1911959 · Received December 1, 2010

    Report

    Report Number
    2122870-2010-00796
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 2, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE CENTRIFUGED FOR 7 MINUTES. QC WAS OUT OF SPECIFICATIONS. A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE (B)(4) 2010 AND NOTICED THE CUSTOMER'S SYSTEM CHECKS WERE FAILING OUT OF SPECIFICATIONS HIGH, WITH THE REPEAT MEETING SPECIFICATIONS. THE FSE PERFORMED A PREVENTIVE MAINTENANCE (PM), MADE A SLIGHT ADJUSTMENT TO THE VOLTAGE ON THE TRANSDUCER AND REPLACED THE SUBSTRATE VALVE AND PERI-PUMP TUBING AFTER OBSERVING THAT THE TUBING WAS FLATTENED. A SYSTEM CHECK THEN PERFORMED MET SPECIFICATIONS. ALTHOUGH HARDWARE ISSUES WERE ADDRESSED BY THE FSE, A CLEAR ROOT CAUSE FOR THIS EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING FALSELY ELEVATED TROPONIN (ACCUTNI) RESULTS GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM FOR THREE PATIENTS' SAMPLES. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. NO REPORTS OF DEATH, INJURY OR CHANGE TO PATIENT TREATMENT HAVE BEEN REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1