BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2904316 · Received January 9, 2013

    Report

    Report Number
    2517506-2013-00008
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 11, 2012
    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
    NJ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    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 SENDING THEIR TACROLIMUS SAMPLES FOR TESTING AT AN ALTERNATE FACILITY. THE REAGENT ISSUE IS UNDER INVESTIGATION BY SIEMENS HEALTHCARE DIAGNOSTICS INC. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 CARTIDGE LOT FA3316. THE RECALL LETTER INSTRUCTED CUSTOMERS TO IMMEDIATELY DISCARD ANY REMAINING REAGENT INVENTORY OF LOT FA3316.

    Description of Event or Problem · 1

    BIASED LOW RESULTS WERE OBTAINED ON TACROLIMUS (TACR) ON QC AND PATIENT SAMPLES IN A LOT CROSSOVER STUDY. THE REAGENT LOT FAILED TO CALIBRATE AND THE REAGENT LOT WAS NOT PUT INTO USE. THE PATIENT RESULTS WERE NOT REPORTED TO THE PHYSICIAN. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. 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
    10648 DIMENSION® CLINICAL CHEMISTRY SYSTEM TACROLIMUS (TACR) FLEX® REAGENT CARTRIDGE MLM SIEMENS HEALTHCARE DIAGNOSTICS INC FA3316

    Patients

    Seq Age Sex Outcome Treatment
    1