BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2112087 · Received June 2, 2011

    Report

    Report Number
    2122870-2011-01669
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 3, 2011
    Report Date
    May 3, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    DHA
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WAS COLLECTED IN BD SERUM SEPARATOR TUBES. SAMPLES WERE CENTRIFUGED FOR 10 MINUTES. QC WAS PERFORMING WITHIN THE CUSTOMER'S ESTABLISHED RANGES AT THE TIME OF EVENT. SYSTEM CHECKS PERFORMED ON (B)(6) 2011 AND (B)(6) 2011 PASSED WITHIN INSTRUMENT SPECIFICATIONS. CUSTOMER DECLINED SERVICE AT THE TIME OF CONTACT WITH BCI HOTLINE. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER INC. (BCI) THAT THE ACCESS 2 IMMUNOASSAY SYSTEM GENERATED A HIGHER THAN EXPECTED BHCG RESULTS FOR ONE (1) PATIENT. REPEAT ANALYSIS OF THE SAMPLE ON THE SAME INSTRUMENT SEVERAL DAYS LATER GENERATED A LOWER RESULT IN A DIFFERENT GESTATIONAL CATEGORY THAT WAS NOT QUESTIONED BY THE CUSTOMER. 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 SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER DHA BECKMAN COULTER INC. ACCESS 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1