BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION RXL MAX WITH HM

    MDR report key: 4256883 · Received November 17, 2014

    Report

    Report Number
    1226181-2014-00593
    Event Type
    Malfunction
    Date Received
    November 17, 2014
    Date of Event
    October 22, 2014
    Report Date
    October 23, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    PDJ
    PMA / PMN Number
    K112999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE CSE EVALUATED THE INSTRUMENT AND INSTRUMENT DATA AND REPLACED THE REAGENT 2 AND REAGENT 3 TRANSDUCER, HEAT TORCH AND LAMP. THE CSE CHECKED ALIGNMENTS AND CLEANED WINDOWS. THE CAUSE OF THE DISCORDANT HB1C RESULTS IS UNKNOWN. THE CSE SUCCESSFULLY RAN QUALITY CONTROLS. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT, FALSELY ELEVATED HEMOGLOBIN A1C (HB1C) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON A DIMENSION RXL MAX WITH HM INSTRUMENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THEM. THE SAMPLES WERE REPEATED ON THE SAME INSTRUMENT. THE CORRECTED HB1C RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HB1C PATIENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742669 DIMENSION RXL MAX WITH HM CLINICAL CHEMSITRY SYSTEM PDJ SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION RXL MAX WITH HM

    Patients

    Seq Age Sex Outcome Treatment
    1