BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA®

    MDR report key: 7009901 · Received November 8, 2017

    Report

    Report Number
    2517506-2017-00788
    Event Type
    Malfunction
    Date Received
    November 8, 2017
    Date of Event
    October 13, 2017
    Report Date
    February 12, 2018
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    CIC
    UDI-DI
    00842768015618
    PMA / PMN Number
    K061792
    Removal / Correction Number
    2517506-02/01/2018-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ORIGINAL MDR 2517506-2017-00788 WAS FILED 11/08/2017. MDR 2517506-2017-00788 SUPPLEMENT 1 WAS FILED 11/30/2017. SIEMENS HEALTHCARE DIAGNOSTICS HAS CONFIRMED THAT DIMENSION VISTA® CALCIUM (CA) FLEX® REAGENT CARTRIDGE LOT 17171BD MAY PRODUCE ERRONEOUSLY LOW RESULTS FROM SPECIFIC WELL SETS. IF CA REAGENT CALIBRATION IS PERFORMED USING AN UNAFFECTED WELL SET AND QC AND PATIENT SAMPLES ARE SUBSEQUENTLY PROCESSED USING AN AFFECTED WELL SET, CA RESULTS MAY BE FALSELY DEPRESSED UP TO -2.8 MG/DL (-0.7 MMOL/L). IF CA REAGENT CALIBRATION IS PERFORMED USING AN AFFECTED WELL SET, AND QC AND PATIENT SAMPLES ARE SUBSEQUENTLY PROCESSED USING AN UNAFFECTED WELL SET, CA RESULTS MAY BE FALSELY ELEVATED. THE OBSERVED BIAS FOR SERUM, PLASMA, AND URINE SPECIMENS ARE SIMILAR. URGENT MEDICAL DEVICE RECALL, VC-18-03.A.US AND URGENT FIELD SAFETY NOTICE VC-18-03.A.OUS DATED JANUARY 2018 WERE ISSUED TO CUSTOMERS WHO HAD BEEN SHIPPED DIMENSION VISTA® CALCIUM (CA) FLEX® REAGENT LOT 17171BD. CUSTOMERS WERE INSTRUCTED TO DISCONTINUE USE AND TO DISCARD LOT 17171BD.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS CUSTOMER CARE CENTER ABOUT THE DISCORDANT FALSELY DEPRESSED CA RESULTS. THE CAUSE OF THE DISCORDANT FALSELY DEPRESSED CA RESULTS IS UNKNOWN. THE INCIDENT IS UNDER INVESTIGATION BY THE SIEMENS HEADQUARTERS SUPPORT CENTER (HSC).

    Additional Manufacturer Narrative · 1

    THE SIEMENS HEALTHCARE DIAGNOSTICS TECHNICAL SOLUTIONS LABORATORY (TSL) AND HEADQUARTERS SUPPORT CENTER (HSC) CONDUCTED FURTHER INVESTIGATION ON LOT 17171BD CALCIUM (CA) FLEX REAGENT CARTRIDGES RETURNED FROM THE CUSTOMER. HEADQUARTERS SUPPORT CENTER (HSC) HAS CONFIRMED THAT WHEN USING THE DIMENSION VISTA CALCIUM (CA) REAGENT LOT 17171BD, QUALITY CONTROL (QC) AND PATIENT SAMPLES MAY SHOW DECREASED RECOVERY OF >0.6 MG/DL (0.15 MMOL/L) WITHIN AN INDIVIDUAL WELL SET. THE ISSUE DOES NOT OCCUR IN EVERY FLEX SEQUENCE AND NOT EVERY WELL SET. SIEMENS IS CONTINUING TO INVESTIGATE THE REAGENT ISSUE.

    Description of Event or Problem · 1

    DISCORDANT FALSELY DEPRESSED CALCIUM (CA) RESULTS WERE OBTAINED ON PATIENT SAMPLES ON THE DIMENSION VISTA 1500 INSTRUMENT. THE ORIGINAL RESULTS WERE REPORTED TO THE PHYSICIAN(S) WHO DID NOT QUESTION THE RESULTS. THE SAME SAMPLES WERE REPEATED ON AN ALTERNATE INSTRUMENT. HIGHER RESULTS WERE OBTAINED. CORRECTED REPORTS WERE ISSUED. AN ADDITIONAL PATIENT WITH AN ORIGINAL DISCORDANT RESULT OF 6.8 MG/DL REGARDED AS DISCORDANT WAS NOTED BUT NO REPEAT RESULT WAS PROVIDED BY THE CUSTOMER. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY DEPRESSED CA RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789039 DIMENSION VISTA® DIMENSION VISTA® CA CALCIUM FLEX® REAGENT CARTRIDGE CIC SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW 17171BD 00842768015618

    Patients

    Seq Age Sex Outcome Treatment
    1