BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY ANALYZER

    MDR report key: 2951125 · Received February 8, 2013

    Report

    Report Number
    2122870-2013-00055
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 15, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    CDD
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER ALSO REPORTED OF OBTAINING AN ERRONEOUSLY LOW VITAMIN B12 RESULT FROM THE SYSTEM FOR ONE PATIENT ON (B)(6) 2013 WHICH WAS NOT REPRODUCIBLE ON (B)(6) 2013. THIS EVENT IS DOCUMENTED IN MDR #2122870-2013-00057.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER THAT THE ACCESS 2 IMMUNOASSAY ANALYZER GENERATED UNREPRODUCIBLE VITAMIN B12 RESULTS FOR THREE PATIENTS IN THE PREVIOUS WEEK. THE CUSTOMER DID NOT PROVIDE PATIENT RESULTS AND EXACT DATE OF THE EVENT. THE RESULT WERE REPORT OUT OF THE LABORATORY. THERE WAS NO REPORT OF DEATH OR INJURY, BUT IT IS UNKNOWN IF THERE WERE ANY CHANGES TO THE PATIENT TREATMENT. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) NOTED THE VALVE MANIFOLD WAS CRACKED AROUND THE WASH VALVE ROTOR. THE FSE REPLACED THE VALVE MANIFOLD AND VERIFIED THE INSTRUMENT PERFORMANCE. THE CUSTOMER USED THE BELOW REAGENT FOR VITAMIN B12 ASSAY: ACCESS B12 REAGENT, CATALOG NUMBER 33000, LOT NUMBER - UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55048 ACCESS® 2 IMMUNOASSAY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE CDD BECKMAN COULTER ACCESS 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1