BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION RXL MAX WITH HM

    MDR report key: 5233234 · Received November 18, 2015

    Report

    Report Number
    1226181-2015-00650
    Event Type
    Malfunction
    Date Received
    November 18, 2015
    Date of Event
    October 21, 2015
    Report Date
    October 22, 2015
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JJE
    PMA / PMN Number
    K112999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC). NO TROUBLESHOOTING WAS REQUESTED FOR DIMENSION RXL MAX WITH HM INSTRUMENT SERIAL NUMBER (B)(4). THE CUSTOMER CALLED REGARDING DIMENSION RXL MAX WITH HM INSTRUMENT SERIAL NUMBER (B)(4). THE CAUSE OF THE DISCORDANT NA, K AND CL RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT POTASSIUM (K) AND SODIUM (NA) RESULTS WERE OBTAINED ON PATIENT SAMPLES (B)(6) ON DIMENSION RXL MAX WITH HM INSTRUMENT SERIAL NUMBER (B)(4). THE RESULTS OBTAINED ON THE INSTRUMENT, DID NOT MATCH BETWEEN THE INITIAL AND REPEAT RUNS WHEN TESTED ON THE SAME INSTRUMENT (SERIAL NUMBER (B)(4)). THE CUSTOMER PROVIDED RAW DATA FOR THE TWO DIMENSION RXL MAX WITH HM INSTRUMENTS (SERIAL NUMBERS (B)(4)). FURTHER DISCORDANT RESULTS WERE FOUND ON NA, K AND CHLORIDE (CL) WHEN THE RESULTS WERE COMPARED BETWEEN THE INSTRUMENTS. THE CUSTOMER DID NOT IDENTIFY ON WHICH INSTRUMENT THE CORRECTED RESULTS WERE OBTAINED. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THEM. THE CUSTOMER STATED THAT AT LEAST ONE PATIENT WAS TREATED BASED ON THE DISCORDANT RESULTS, BUT DID NOT IDENTIFY WHICH PATIENT. THE SAMPLES WERE REPEATED ON THE SAME INSTRUMENT AND ON AN ALTERNATE DIMENSION RXL MAX WITH HM INSTRUMENT (SERIAL NUMBER: (B)(4)), AND RESULTS WERE EITHER LOWER OR HIGHER THAN THE INITIAL RESULTS. CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT NA, K AND CL RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764535 DIMENSION RXL MAX WITH HM CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION RXL MAX WITH HM

    Patients

    Seq Age Sex Outcome Treatment
    1