BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY CLINICAL SYSTEM

    MDR report key: 1884370 · Received October 27, 2010

    Report

    Report Number
    2122870-2010-00656
    Event Type
    Malfunction
    Date Received
    October 27, 2010
    Date of Event
    September 21, 2010
    Report Date
    October 27, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE SERUM COLLECTED IN SERUM SEPARATOR TUBES. THESE WERE THEN ALIQUOTED AND FROZEN UNTIL ANALYZED. THE ALIQUOT TUBES WERE NOT RE-CENTRIFUGED PRIOR TO ANALYSIS. QC IS PERFORMED ONCE EVERY 24 HOURS AND WAS WITHIN THE ESTABLISHED RANGES DURING THIS EVENT. THE CUSTOMER IMPLEMENTED A NEW POLICY TO REPEAT ALL VITAMIN B12 RESULTS OF LESS THAN 179 PG/ML SINCE THIS EVENT. THE CUSTOMER HAS A SERVICE CONTRACT WITH A THIRD PARTY VENDOR. THE SERVICE NOTES WERE NOT AVAILABLE. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) IN REGARDS TO ERRONEOUSLY LOW VITAMIN B12 RESULTS GENERATED ON ACCESS 2 IMMUNOASSAY SYSTEM FOR FOUR PATIENTS' SAMPLES. THREE OF THE RESULTS WERE BELOW THE NORMAL REFERENCE RANGE. THE RESULTS WERE REPORTED OUT OF THE LABORATORY AND WERE QUESTIONED BY THE PHYSICIANS. SUBSEQUENT TESTING PRODUCED HIGHER VITAMIN B12 RESULTS WITHIN THE NORMAL REFERENCE RANGE. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1