BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION(R) CLINICAL CHEMISTRY SYSTEM

    MDR report key: 3001406 · Received March 13, 2013

    Report

    Report Number
    2517506-2013-00098
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    October 20, 2012
    Report Date
    February 20, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    LCP
    PMA / PMN Number
    K102510
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE (B)(6) RESULTS IS USER ERROR. THE ACCOUNT FAILED TO INPUT THE CORRECT LOT SPECIFIC CALIBRATOR BOTTLE VALUES FOR THE LOT OF (B)(6) REAGENT. THE (B)(6) RESULTS WERE CAUSED BY USING INCORRECT BOTTLE VALUES AND THE ISSUE WAS RESOLVED BY ENTERING CORRECT BOTTLE VALUES AND VERIFYING WITH QC. THE (B)(6) METHOD INSTRUCTION FOR USE CLEARLY STATES: "EACH KIT CONTAINS MATCHED SETS OF (B)(6) FLEX(R) REAGENT CARTRIDGES AND CALIBRATORS. THESE COMPONENTS ARE NOT INTERCHANGEABLE BETWEEN LOTS WITH DIFFERENT LOT NUMBERS." THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A GROUP OF (B)(6) RESULTS WAS OBTAINED ON QC AND PATIENT SAMPLES. THE RESULTS WERE REPORTED TO THE PHYSICIANS. THE RESULTS WERE EVENTUALLY QUESTIONED AND IT WAS DETERMINED THAT INCORRECT CALIBRATOR BOTTLE VALUES HAD BEEN IN USE. IT IS UNKNOWN IF PATIENT TREATMENT WAS ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE (B)(6) RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104610 DIMENSION(R) CLINICAL CHEMISTRY SYSTEM HEMOGLOBIN A1C KIT LCP SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW GB3211

    Patients

    Seq Age Sex Outcome Treatment
    1