BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION EXL 200

    MDR report key: 5699281 · Received June 3, 2016

    Report

    Report Number
    1226181-2016-00307
    Event Type
    Malfunction
    Date Received
    June 3, 2016
    Date of Event
    May 8, 2016
    Report Date
    July 29, 2016
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JJE
    PMA / PMN Number
    K073604
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR 1226181-2016-00307 WAS FILED ON JUNE 03, 2016. THE SUPPLEMENTAL MDR 1226181-2016-00307_S1 WAS FILED ON JUNE 20, 2016. CORRECTED INFORMATION: (07/29/2016): THE 510(K) NUMBER, K130276, IN THE INITIAL MDR WAS INCORRECT. THE 510(K) NUMBER PORTION HAS BEEN UPDATED WITH THE CORRECT 510(K) NUMBER.

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR 1226181-2016-00307 WAS FILED ON JUNE 03, 2016. ADDITIONAL INFORMATION (06/07/2016): SIEMENS CUSTOMER CARE CENTER (CCC) FOLLOWED UP WITH THE CUSTOMER. THE CUSTOMER MONITORED THE INSTRUMENT AND NO FURTHER DISCORDANT RESULTS WERE OBTAINED ON OTHER SAMPLES. THE CAUSE OF THE DISCORDANT, FALSELY DEPRESSED SODIUM AND POTASSIUM RESULTS ON ONE PATIENT SAMPLE IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC) FOR TROUBLESHOOTING ON OTHER DIMENSION EXL INSTRUMENT. SIEMENS IS INVESTIGATING THE ISSUE.

    Description of Event or Problem · 1

    DISCORDANT, FALSELY DEPRESSED SODIUM (NA) AND POTASSIUM (K) RESULTS WERE OBTAINED ON ONE PATIENT SAMPLE UPON REPEAT TESTING ON A DIMENSION EXL 200 INSTRUMENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS INITIALLY TESTED ON AN ALTERNATE DIMENSION INSTRUMENT, RESULTING FALSELY LOW. THE SAMPLE WAS REPEATED AGAIN ON THIS DIMENSION EXL 200 (SERIAL NUMBER (B)(4)), STILL RESULTING FALSELY LOW. THE SAMPLE WAS REPEATED AGAIN, RESULTING HIGHER THAN ALL PREVIOUS RESULTS. THE CUSTOMER DID NOT SPECIFY THE INSTRUMENT ON WHICH THESE RESULTS WERE OBTAINED. THE CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY DEPRESSED NA AND K RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351672 DIMENSION EXL 200 CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION EXL 200

    Patients

    Seq Age Sex Outcome Treatment
    1