BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 4929873 · Received July 21, 2015

    Report

    Report Number
    2517506-2015-00167
    Event Type
    Malfunction
    Date Received
    July 21, 2015
    Date of Event
    July 13, 2015
    Report Date
    September 17, 2015
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    JGJ
    PMA / PMN Number
    K140790
    Removal / Correction Number
    2517506-09292015-006-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ORIGINAL MDR SUBMITTED (B)(6) 2015. SIEMENS HEALTHCARE DIAGNOSTICS HAS RECEIVED CUSTOMER COMPLAINTS FOR THE DIMENSION VISTA MAGNESIUM (MG) LOT 15063BA. THE COMPLAINTS WERE RELATED TO ERRONEOUS LOW RESULTS ON A SMALL NUMBER OF REAGENT WELLS. SIEMENS HEALTHCARE DIAGNOSTICS ISSUED AN URGENT MEDICAL DEVICE RECALL COMMUNICATION VC-15-12.A.US DATED SEPTEMBER 2015 INSTRUCTING CUSTOMERS TO DISCONTINUE USE AND DISCARD ANY REMAINING INVENTORY OF THE AFFECTED LOT AND TO CONTACT SIEMENS HEALTHCARE DIAGNOSTICS FOR REPLACEMENT PRODUCT. DATA COLLECTED FROM THE CUSTOMER COMPLAINTS SHOWS THAT THERE IS THE POTENTIAL FOR UNDER-RECOVERY ON CERTAIN WELLS FOR QUALITY CONTROL(QC) AND PATIENT SAMPLE RESULTS. WHEN THIS ISSUE OCCURRED, THE UNDER-RECOVERY RANGED FROM -0.3 MG/DL [0.12 MMOL/L] TO - 1.6 MG/DL [0.66 MMOL/L]. THE AVERAGE UNDER-RECOVERY WAS -1.0 MG/DL [0.41 MMOL/L]. THIS ISSUE IS DEMONSTRATING A LOW FREQUENCY OF OCCURRENCE WITH AN ESTIMATE ONE (1) IN EVERY 10,000 TESTS MAY BE AFFECTED. REPEATING THE SAMPLE ON A NEW WELL OR A NEW FLEX CARTRIDGE RESOLVES THE ISSUE. THIS ISSUE IS LIKELY TO BE DETECTED BY QUALITY CONTROL (QC) OR CALIBRATORS IF THEY ARE RUN ON THE AFFECTED WELLS OF REAGENT.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY DEPRESSED MG RESULTS IS UNKNOWN. HOWEVER, THE INSTRUMENT DATA SHOWS THE CLUSTER OF DEPRESSED MG RESULTS WAS RESTRICTED TO A REAGENT WELL PAIR IN THE MG FLEX REAGENT CARTRIDGE. THE ISSUE IS UNDER INVESTIGATION BY (B)(4).

    Description of Event or Problem · 1

    DISCREPANT DEPRESSED MAGNESIUM (MG) RESULTS WERE OBTAINED ON PATIENT SAMPLES. IT IS UNKNOWN IF PATIENT RESULTS WERE REPORTED TO PHYSICIANS. THE ACCOUNT REPEATED THE SAMPLES ON AN ALTERNATE REAGENT WELL SET OF THE SAME FLEX(R) REAGENT CARTRIDGE AND HIGHER RESULTS WERE OBTAINED. IT IS UNKNOWN IF PATIENT TREATMENT WAS ALTERED OR PRESCRIBED ON THE BASIS OF THE FALSELY DEPRESSED MG RESULTS. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY DEPRESSED MG RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474098 DIMENSION VISTA® CLINICAL CHEMISTRY SYSTEM MAGNESIUM FLEX® REAGENT CARTRIDGE JGJ SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW 15063BA

    Patients

    Seq Age Sex Outcome Treatment
    1