BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA 1500

    MDR report key: 7905768 · Received September 25, 2018

    Report

    Report Number
    2517506-2018-00548
    Event Type
    Malfunction
    Date Received
    September 25, 2018
    Date of Event
    August 30, 2018
    Report Date
    September 25, 2018
    Manufacturer
    SIEMENS HEATLHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC) AND REPORTED THAT A DISCORDANT, FALSELY LOW GLU RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE CCC SPECIALIST REVIEWED THE INSTRUMENT FILES AND DETERMINED THAT QUALITY CONTROL RESULTS RECOVERED WITHIN EXPECTED RANGES ON THE DAY OF THE EVENT. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE CSE RAN SERVICE METHOD TESTS (SMT) ON ALIGNMENTS ON SAMPLE PROBE 1, REAGENT PROBE 1, AND REAGENT PROBE 2, REALIGNED S1 AND R1, REPEATED SMT ON ALIGNMENT FOR S1 AND R1, AND RAN MIX TEST SMT FOR S1, R1 AND R2. THE MIX TEST AND ALIGNMENT SMT TESTS RECOVERED WITHIN SPECIFICATIONS. THEN, THE CSE RAN QUALITY CONTROLS (QCS), RESULTING ACCEPTABLY. THE CAUSE OF THE DISCORDANT, FALSELY LOW GLU RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY LOW GLUCOSE (GLU) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION VISTA 1500 INSTRUMENT. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED TWICE ON THE SAME INSTRUMENT , RESULTING HIGHER. THE REPEAT RESULT OF 82 MG/DL WAS REPORTED AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW GLU RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748345 DIMENSION VISTA 1500 CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEATLHCARE DIAGNOSTICS INC. DIMENSION VISTA 1500

    Patients

    Seq Age Sex Outcome Treatment
    1