BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA 1500

    MDR report key: 12108347 · Received July 2, 2021

    Report

    Report Number
    2517506-2021-00150
    Event Type
    Malfunction
    Date Received
    July 2, 2021
    Date of Event
    June 9, 2021
    Report Date
    August 12, 2021
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 2517506-2021-00150 ON 02JUL2021. ADDITIONAL INFORMATION (21JUL2021): THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC) AND A SIEMENS CUSTOMER SERVICE SPECIALIST (CSS) REVIEWED THE INFORMATION PROVIDED. A REVIEW OF THE DIMENSION VISTA 1500 (SN: (B)(6)) INSTRUMENT DID NOT FIND ANY ANOMALIES OR ISSUES WITH THE INSTRUMENT. HOWEVER, A REVIEW OF THE ASPIRATION PROFILE ON DIMENSION VISTA 1500 (SN: (B)(6)) SHOWED THE UNDILUTED SAMPLE HAD AN ATYPICAL ASPIRATION PROFILE INDICATING A POTENTIAL SAMPLE ISSUE SUCH AS PARTIAL CLOTS, OR HIGHER SAMPLE VISCOSITY. THE CALCULATED VALUES FOR THE REACTIONS SHOWS THAT A FLEX SEQUENCE NUMBER HAD AN ATYPICALLY HIGH POLISHED MILLIABSORBANCE UNITS (MAU) FOR BOTH OF THE REACTION READ POINTS COMPARED TO ALL OTHER REAGENT FLEX CARTRIDGES. ALLIANCE APPLICATIONS REAGENT FLEX CARTRIDGES ARE EMPTY CARTRIDGES THAT ARE MANUALLY FILLED WITH THE ALLIANCE APPLICATION BULK REAGENT BY THE OPERATOR BEFORE LOADING ON THE ANALYZER. CONSULTATION WITH THE BULK REAGENT MANUFACTURER CONFIRMED THAT THIS INCREASE IN THE POLISHED MAU IS CONSISTENT WITH THE REAGENT 1 AND THE REAGENT 2 BEING SWITCHED IN THE REAGENT FLEX CARTRIDGE. THIS LED TO A CHANGE IN THE CURVE SHAPE WHERE SAMPLES ABOVE THE ASSAY RANGE COULD RECOVER WITHIN THE ASSAY RANGE. QUALITY CHECKS (QC) PERFORMED OUT OF THE AFFECTED REAGENT CARTRIDGE SHOWED A SHIFT DOWN IN RECOVERY COMPARED TO OTHER DATA POINTS BUT WAS WITHIN THE OPERATOR RANGES. SIEMENS FOUND THAT THIS WAS THE ONLY FLEX REAGENT CARTRIDGE TO DEMONSTRATE THIS ISSUE. SIEMENS CONFIRMED THAT THE CAUSE OF THE ISSUE IS THE INCORRECT FILLING OF THE SINGLE REAGENT FLEX CARTRIDGE LEADING TO REAGENT 1 AND REAGENT 2 TO BE SWAPPED. SYSTEM IS FULLY OPERATIONAL. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED. MDR 2517506-2021-00149_S1 WAS FILED IN CONJUNCTION TO THIS REPORT.

    Additional Manufacturer Narrative · 1

    SIEMENS IS INVESTIGATING THE ISSUE. MDR 2517506-2021-00149 WAS FILED IN CONJUNCTION TO THIS REPORT FOR DIMENSION VISTA 1500 INSTRUMENT (SERIAL: (B)(4)).

    Description of Event or Problem · 1

    MULTIPLE DISCORDANT, FALSELY DEPRESSED METHOTREXATE TEST RESULTS WERE OBTAINED ON A PATIENT SAMPLE, ON A DIMENSION VISTA 1500 (SERIAL: (B)(4)) INSTRUMENT. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPEATED ON THE SAME INSTRUMENT AND AN ALTERNATE DIMENSION VISTA 1500 (SERIAL: SERIAL: (B)(4)) INSTRUMENT. THE SAMPLE WAS DILUTED 100-FOLD AND REPEATED ON THE ALTERNATE DIMENSION VISTA 1500 INSTRUMENT AND THE ORIGINAL INSTRUMENT. THE CUSTOMER STATED THAT THE PHYSICIAN(S) EXPECTED A MUCH HIGHER RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED METHOTREXATE PATIENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1007019 DIMENSION VISTA 1500 DIMENSION VISTA 1500 JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA 1500

    Patients

    Seq Age Sex Outcome Treatment
    1