BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 3241317 · Received July 22, 2013

    Report

    Report Number
    2517506-2013-00321
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 26, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    MLM
    PMA / PMN Number
    K060502
    Removal / Correction Number
    2517506-11-27-2012-018-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 13-05 INSTRUCTED CUSTOMERS TO IMMEDIATELY DISCONTINUE USE AND DISCARD ANY REMAINING REAGENT INVENTORY OF LOT FA3316. IN THIS INSTANCE, THE CUSTOMER WAS PROVIDED AN ALTERNATE SIEMENS HEALTHCARE DIAGNOSTICS INC. INSTRUMENT SYSTEM (VIVA E) WHICH PROVIDED THEM AN ALTERNATIVE METHOD TO TEST PATIENT SAMPLES. THE VIVA E SYSTEM APPEARS TO HAVE PERFORMED ACCORDING TO ITS SPECIFICATIONS. IN TESTING IN A BATCH MODE RATHER THAN IN RANDOM ACCESS MODE, THE CUSTOMER DID NOT PROVIDE RESULTS AS QUICKLY AS ON THE DIMENSION SYSTEM. IT IS ALLEGED THAT THIS DELAYED MODE OF RESULT REPORTING MAY HAVE CONTRIBUTED TO LOSS OF A TRANSPLANTED ORGAN.

    Description of Event or Problem · 1

    A CUSTOMER NOTIFIED SIEMENS HEALTHCARE DIAGNOSTICS ABOUT AN ISSUE REPORTEDLY RELATED TO A FIELD CORRECTION (URGENT MEDICAL DEVICE RECALL) OF JANUARY 2013 INFORMING CUSTOMERS TO DISCONTINUE USE OF THE DIMENSION(R) TACROLIMUS LOT FA3316 AND TO INFORM THEM THAT NO OTHER LOTS WERE AVAILABLE. THE CUSTOMER WAS PROVIDED WITH AN ALTERNATE SIEMENS HEALTHCARE DIAGNOSTICS INSTRUMENT SYSTEM (VIVAE) WHICH PROVIDED AN ALTERNATIVE METHOD TO TEST PATIENT SAMPLES. THE ALTERNATE INSTRUMENT SYSTEM REQUIRES A MANUAL PRETREATMENT STEP WHEREAS THE DIMENSION(R) SYSTEM PERFORMED AN AUTOMATED DILUTION. ALSO, FOR THE ALTERNATE SYSTEM, THE CUSTOMER REPORTEDLY CHOSE TO RUN THEIR PATIENT SAMPLES IN BATCH MODE RATHER THAN RANDOM ACCESS MODE AS EACH SAMPLE ARRIVED IN THE LABORATORY. DUE TO THE RECALL OF LOT FA3316, AND THE TEMPORARY NON-AVAILABILITY OF THE DIMENSION TACROLIMUS ASSAY, THE DELAYED MODE OF RESULT REPORTING ASSOCIATED WITH MANUAL PRETREATMENT AND RUNNING OF PATIENT SAMPLES IN BATCH RATHER THAN RANDOM ACCESS MODE IS ALLEGED TO HAVE CONTRIBUTED TO THE LOSS OF THE PATIENT'S TRANSPLANTED KIDNEY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339971 DIMENSION® CLINICAL CHEMISTRY SYSTEM TACROLIMUS FLEX® REAGENT CARTRIDGE MLM SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW FA3316

    Patients

    Seq Age Sex Outcome Treatment
    1 Other