BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® HTSH REAGENT

    MDR report key: 2172779 · Received July 22, 2011

    Report

    Report Number
    2122870-2011-02198
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    May 20, 2011
    Report Date
    June 17, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JLW
    PMA / PMN Number
    K954825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: ERRONEOUS DATA GENERATED. CONCLUSION: A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER HAD POSTED RESULTS ON THE AMERICAN (B)(6) WEB SITE REGARDING INCONSISTENT RESULTS FOR THYROID STIMULATING HORMONE (TSH) FOR ONE PATIENT WHOSE SAMPLES WERE ASSAYED WITH ACCESS HYPERSENSITIVE HTSH REAGENT. THE PATIENT DID NOT CONTACT BECKMAN COULTER, INC. (BCI) DIRECTLY. BCI FOLLOWED UP WITH THE CUSTOMER AFTER THE RESULTS POSTED ON (B)(6)'S WEB SITE WERE DISCOVERED. THE PATIENT RESULTS WERE REPORTED OUT OF THE LABORATORY. IT IS UNKNOWN IF THERE WAS ANY IMPACT TO PATIENT TREATMENT AS A RESULT OF THIS EVENT. THE CUSTOMER POSTED TSH RESULTS FOR THE SAME PATIENT DRAWN FIVE DAYS APART. ON THE FIRST DRAW, THE PATIENT'S TSH RESULT RECOVERED ABOVE THE LABORATORY'S NORMAL REFERENCE RANGE. ON THE SECOND DRAW FIVE DAYS LATER, THE PATIENT'S TSH RESULT RECOVERED WITHIN THE LABORATORY'S NORMAL REFERENCE RANGE. BCI FOLLOWED UP WITH THE CUSTOMER. THE CUSTOMER REPORTED THAT HE WAS MADE AWARE OF THIS EVENT ABOUT A MONTH AFTER IT OCCURRED AND THAT FURTHER INVESTIGATION NOW WOULD NOT BE BENEFICIAL. THE CUSTOMER REPORTED THAT HE DOES NOT BELIEVE THE RESULTS FROM THIS EVENT REPRESENT A TREND (OTHERWISE, HE WOULD HAVE INITIATED CONTACT WITH BCI). NO SPECIFIC INFORMATION WAS PROVIDED REGARDING WHICH ANALYZER WAS USED TO GENERATE THE TSH RESULTS. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® HTSH REAGENT THYROID STIMULATING HORMONE TEST SYSTEM JLW BECKMAN COULTER, INC. (NOT SUPPLIED)

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR