BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2060396 · Received April 15, 2011

    Report

    Report Number
    2122870-2011-01013
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 17, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    CEW
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE COLLECTION OR CENTRIFUGATION DATA WAS SUPPLIED TO DATE. QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO THE EVENT. WHILE TROUBLESHOOTING WITH THE BCI HOTLINE IT WAS DETERMINED THAT THE INTACT PTH REAGENT PACK WAS MISLOADED AND THEREFORE IN THE INCORRECT SLOT OF THE REAGENT STORAGE CAROUSEL. THIS INDICATES THAT THE CUSTOMER DID NOT FOLLOW THE PUBLISHED DIRECTIONS FOR LOADING A REAGENT PACK. WHEN THIS OCCURS THE INSTRUMENT DOES NOT DETECT EITHER A WRONG REAGENT PACK OR NO REAGENT PACK IS PRESENT. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. USER ERROR IS THE ROOT CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI), IN REGARDS TO OBTAINING REPEATABLE ERRONEOUSLY LOW RESULTS BELOW THE REFERENCE INTERVAL FOR INTACT PARATHYROID HORMONE (PTH) ON TWO DIFFERENT SAMPLES FROM THE SAME PATIENT THAT WERE GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM. THE CUSTOMER ALSO OBTAINED 0 NG/ML RESULTS FOR ALL LEVELS OF QC. NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER REPORTED THAT THE PATIENT'S SURGERY WAS DELAYED FOR SEVERAL HOURS DUE TO THIS EVENT. HOWEVER, NO DEATH OR SERIOUS INJURY WAS REPORTED FOR THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other