BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2937966 · Received January 31, 2013

    Report

    Report Number
    2517506-2013-00027
    Event Type
    Malfunction
    Date Received
    January 31, 2013
    Date of Event
    December 14, 2012
    Report Date
    January 10, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    MLM
    PMA / PMN Number
    K060502
    Removal / Correction Number
    2517506-11-27-2012-018-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE BIASED LOW TACROLIMUS RESULTS IS UNKNOWN. THE ACCOUNT IS NOT USING THE FA3316 REAGENT LOT. THE REAGENT ISSUE IS UNDER INVESTIGATION BY SIEMENS HEALTHCARE DIAGNOSTICS INC. SIEMENS HEALTHCARE DIAGNOSTICS INC. ISSUED AN URGENT MEDICAL DEVICE RECALL ON 01-15-2013. THE RECALL LETTER CONFIRMED THE COMPLAINT OF LOW QC AND PATIENT SAMPLE RECOVERIES WITH THE DIMENSION TACR FLEX REAGENT CARTRIDGE LOT FA3316. THE RECALL LETTER INSTRUCTED CUSTOMERS TO IMMEDIATELY DISCARD ANY REMAINING REAGENT INVENTORY OF LOT FA3316. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    BIASED LOW RESULTS WERE OBTAINED ON TACROLIMUS (TACR) ON QC AND PATIENT SAMPLES IN A LOT CROSSOVER STUDY VERSUS AN ALTERNATE METHODOLOGY / ALTERNATE INSTRUMENT SYSTEM. THE PATIENT RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THE BIAS WAS NOTED BY THE LABORATORY AND THEY DID NOT PUT THE LOT INTO USE. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED ON THE BASIS OF THE BIASED LOW TACR RESULTS. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE BIASED LOW TACROLIMUS RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42864 DIMENSION® CLINICAL CHEMISTRY SYSTEM TACROLIMUS (TACR) FLEX® REAGENT CARTRIDGE MLM SIEMENS HEALTHCARE DIAGNOSTICS INC FA3316

    Patients

    Seq Age Sex Outcome Treatment
    1