BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2517506-2017-00415

    MDR report key: 6513049 · Received April 21, 2017

    Report

    Report Number
    2517506-2017-00415
    Event Type
    Malfunction
    Date Received
    April 21, 2017
    Date of Event
    March 30, 2017
    Report Date
    April 21, 2017
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEALTHCARE DIAGNOSTICS INC. (SIEMENS) CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE CSE ALIGNED AND CLEANED REAGENT PROBES 1 AND 2 AND PRIMED REAGENT PROBES 1 AND 2 AND SAMPLE PROBE 1 (S1). SERVICE METHODS WERE PERFORMED. DURING FOLLOW-UP VISITS, THE CSE REPLACED THE ALIQUOT PROBE AND THE INTEGRATED MULTI-SENSOR TECHNOLOGY PROBE AND RAN A QUICK CHECK. THE CSE CLEANED ALL DRAINS AND ADJUSTED VACUUM, REPLACED S1 MIXER AND PROBE AND PERFORMED MIXER DIAGNOSTICS TEST. QUICK CHECK AND ALL FUNCTIONAL TESTS WERE ACCEPTABLE. THE CSE CALIBRATED AND RAN QC FOR HEMOGLOBIN A1C AND PERFORMED PRECISION TESTING ON PATIENT SAMPLES, ALL OF WHICH WERE ACCEPTABLE. THE CAUSE OF THE DISCORDANT HEMOGLOBIN A1C RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT HEMOGLOBIN A1C RESULTS WERE OBTAINED FROM A DIMENSION VISTA 500 INSTRUMENT. THE RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. REPEAT TESTING USING THE SAME SAMPLES WAS PERFORMED ON THE SAME DIMENSION VISTA 500 INSTRUMENT. SOME SAMPLES WERE REPEATED A SECOND TIME. THE REPEAT RESULTS WERE REPORTED TO THE PHYSICIAN(S).

    Patients

    Seq Age Sex Outcome Treatment
    1