BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA 1500

    MDR report key: 12289181 · Received August 6, 2021

    Report

    Report Number
    2517506-2021-00177
    Event Type
    Malfunction
    Date Received
    August 6, 2021
    Date of Event
    April 15, 2021
    Report Date
    August 6, 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 · 1

    THE CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER AND NOTIFIED SIEMENS THAT DISCORDANT RESULTS WERE OBTAINED FROM USER DEFINED METHOD (METHOTREXATE) ON THE DIMENSION VISTA 1500 INSTRUMENT. THE CUSTOMER INDICATED THAT CALIBRATION AND QUALITY CONTROLS (QC) WERE WITHIN ACCEPTABLE RANGES ON THE DAY OF THE EVENT. SIEMENS DISPATCHED A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) TO THE CUSTOMER'S SITE. THE CSE RAN SERVICE METHODS AND PERFORMED BOTTOM OF CUVETTE ALIGNMENTS FOR REAGENT PROBE 2 (R2) AND SAMPLE PROBE 1 (S1). ALL OTHER FUNCTIONS WERE WITHIN SPECIFICATIONS. QUALITY CONTROLS (QC) WERE RUN AND RECOVERED WITHIN RANGE. ADDITIONALLY, QC SAMPLES USING DILUTIONS WERE TESTED AT THE SAME TIME AND RECOVERED AS EXPECTED. CALIBRATION AND QC WERE WITHIN SPECIFICATIONS WHEN THE ORIGINAL SAMPLE WAS FIRST PROCESSED. ON 15-APR-2021, A CALIBRATION SHOWED INCREASED IMPRECISION WHICH WAS ADDRESSED WITH AN ALIGNMENT OF THE ALIQUOT PROBE. WHILE THE IMPRECISION SEEN COULD AMPLIFY THE DISCREPANCY, IT WOULD AMOUNT TO A 5 - 10 MILLIABSORBANCE UNIT (MAU) SHIFT IN THE RAW PHOTOMETRIC SIGNAL. THE DISCORDANT SAMPLES HAD > 30 MAU SHIFTS. ADDITIONALLY, SIEMENS CANNOT RULE OUT ISSUES WITH THE MANUAL PIPETTES USED TO MAKE THE DILUTIONS, ISSUES WITH MAKING THE DILUTIONS, OR ISSUES WITH THE DILUENT BUFFER USED AT THE CUSTOMER SITE. THE PRESENCE OF ATYPICAL PROTEINS IN THE SAMPLE FROM THE PATIENT'S CLINICAL CONDITION CAN AFFECT THE VISCOSITY AND ABILITY OF THE SAMPLE TO BE ACCURATELY PIPETTED. ISSUES WERE NOT FOUND WITH THE REAGENT OR CALIBRATOR. THE REAGENT PERFORMED TO EXPECTATIONS WHEN FOLLOWING THE SAMPLE SERIAL DILUTION PROTOCOL IN APPLICATION SHEET. THE CAUSE OF THE ISSUE IS UNKNOWN. SIEMENS REVIEWED INSTRUMENT FILES TO FURTHER INVESTIGATE THIS COMPLAINT. SIEMENS DETERMINED THAT QUALITY CONTROL SAMPLES USING DILUTIONS WERE TESTED AT THE SAME TIME AND RECOVERED AS EXPECTED. ALL REACTION READS WERE WITHIN TYPICAL PERFORMANCE. THE ISSUE WAS LIMITED TO THIS SINGLE SAMPLE. CALIBRATION AND QC WERE WITHIN SPECIFICATIONS WHEN THE ORIGINAL SAMPLE WAS FIRST PROCESSED. ON 15-APR-2021, A CALIBRATION SHOWED INCREASED IMPRECISION WHICH WAS ADDRESSED WITH PROBE ALIGNMENTS. WHILE THE IMPRECISION SEEN COULD AMPLIFY THE DISCREPANCY, IT WOULD AMOUNT TO A 5 - 10 MILLI-ABSORBANCE UNIT (MAU) SHIFT IN THE RAW PHOTOMETRIC SIGNAL. MOST OF THE DISCORDANT RESULTS > 30 MAU SHIFTS. SIEMENS DETERMINED THAT ISSUES WITH THE MANUAL PIPETTES USED TO MAKE THE DILUTIONS, ISSUES WITH MAKING THE DILUTIONS, OR ISSUES WITH THE DILUENT BUFFER USED AT THE CUSTOMER SITE POTENTIALLY CONTRIBUTED TO THE DIFFERENT METHOTREXATE RESULTS. ADDITIONALLY, THE PRESENCE OF ATYPICAL PROTEINS IN THE SAMPLE FROM THE PATIENT'S CLINICAL CONDITION CAN AFFECT THE VISCOSITY AND ABILITY OF THE SAMPLE TO BE ACCURATELY PIPETTED. ISSUES WERE NOT FOUND WITH THE REAGENT OR CALIBRATOR. THE REAGENT PERFORMED TO EXPECTATIONS WHEN FOLLOWING THE SAMPLE SERIAL DILUTION PROTOCOL IN APPLICATION SHEET. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED. MDR 2517506-2021-00111 AND ITS SUPPLEMENTAL WERE FILED FOR THE SAME EVENT.

    Description of Event or Problem · 1

    DIFFERENT METHOTREXATE (XMTX) RESULTS WERE OBTAINED ON A PATIENT SAMPLE THAT WAS DILUTED IN SEVERAL DILUTIONS ON A DIMENSION VISTA 1500 INSTRUMENT. THE CUSTOMER ALSO REPEATED THE SAMPLE ON AN ALTERNATE DIMENSION VISTA INSTRUMENT AND A XMTX RESULT OF 1530 MOL/L WAS OBTAINED ON THE PATIENT SAMPLE. THE RESULT FROM THE ALTERNATE INSTRUMENT WAS REPORTED TO THE PHYSICIAN(S) AS CORRECT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DIFFERENT XMTX RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1188580 DIMENSION VISTA 1500 DIMENSION VISTA 1500 JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA 1500

    Patients

    Seq Age Sex Outcome Treatment
    1