BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATUS CS

    MDR report key: 1870622 · Received October 7, 2010

    Report

    Report Number
    MW5017710
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 7, 2010
    Manufacturer
    SIEMENS CORP.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    I AM A LAB MANAGER THAT HAS DEEP CONCERNS ABOUT THE TEST KIT QUALITY AND INSTRUMENT PERFORMANCE OF THE STRATUS CS BEING MFG AND SOLD BY THE SIEMENS CORP. OVER THE PAST FOUR YRS, I HAVE DEALT WITH NUMEROUS URGENT SAFETY NOTICES. I HAVE HAD GREAT VARIANCES IN THE CONCENTRATIONS OF REAGENT LOTS BEING SENT TO ME TO INCLUDE TPN-I, P-BNP AND D-DIMER. LASTLY, I HAVE HAD NUMEROUS ONGOING ISSUES WITH THE INSTRUMENT PERFORMANCE TO INCLUDE LAMP INTENSITY, LAMP MANAGERS AND THE FLUOROMETER. I AM CURRENTLY MOVING THE TPN-I AND P-BNP TEST TO MY DIMENSION XPAND SO I NO LONGER HAVE TO DEAL WITH CONSTANT HEADACHES. I HOPE THAT SOMEONE CAN LOOK INTO THIS ONE DAY IN ORDER TO HELP LAB PROFESSIONALS, AS WELL AS, THE PATIENTS THEY SERVE. I APPRECIATE YOUR TIME. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATUS CS IMMUNOASSY INSTRUMENT JJE SIEMENS CORP. 230236002
    2 TPN-I - 10 IMMUNOASSY INSTRUMENT JJE SIEMENS CORP
    3 P-BNP IMMUNOASSY INSTRUMENT JJE SIEMENS CORP
    4 D-DIMER IMMUNOASSY INSTRUMENT JJE SIEMENS CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization