BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION EXL WITH LM

    MDR report key: 5660737 · Received May 17, 2016

    Report

    Report Number
    1226181-2016-00286
    Event Type
    Malfunction
    Date Received
    May 17, 2016
    Date of Event
    April 20, 2016
    Report Date
    May 17, 2016
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JJE
    PMA / PMN Number
    K130276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) SPECIALIST WAS DISPATCHED TO THE CUSTOMER SITE ON APRIL 25, 2016. AFTER EVALUATING THE INSTRUMENT, THE CSE REPLACED THE SAMPLE TUBING DUE TO THE KINKS IN THE OLD TUBING. THE CSE ALSO REPLACED THE SALT BRIDGE BOTTLE CAP AND TUBING, BLEACHED AND FLUSHED THE INTEGRATED MULTI-SENSOR TECHNOLOGY (IMT) PORT, ADJUSTED THE IMT PUMP RATE AND CALIBRATED THE IMT. A SYSTEM CHECK WAS PERFORMED AND QUALITY CONTROLS (QC) WERE RUN, WHICH WERE ACCEPTABLE. THE CSE DISCOVERED THAT ON THE DAY DISCORDANT RESULTS WERE OBTAINED THE CUSTOMER RAN LEVEL 2 QC FROM A LEVEL 1 QC VIAL. THE CSE RAN LEVEL 1 QC FROM A LEVEL 1 QC VIAL AND THE RESULTS WERE ACCEPTABLE. A SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) SPECIALIST REVIEWED THE INSTRUMENT DATA. THE HSC SPECIALIST RECOMMENDED THE CUSTOMER TO FOLLOW PROPER PRE-ANALYTICAL SAMPLE HANDLING PROCEDURES. THE CAUSE OF THE DISCORDANT RESULTS ON MULTIPLE PATIENT SAMPLES IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC) AND STATED THAT DISCORDANT SODIUM (NA) AND CHLORIDE (CL) RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES AND A DISCORDANT POTASSIUM (K) RESULT WAS OBTAINED ON ONE OF THE PATIENT SAMPLES ON A DIMENSION EXL WITH LM INSTRUMENT. THE CCC SPECIALIST RECOMMENDED THE CUSTOMER TO STOP USING THE INSTRUMENT FOR TESTING UNTIL AFTER A SERVICE VISIT. A SERVICE VISIT WAS SCHEDULED FOR (B)(6) 2016. THE CUSTOMER CONTINUED RUNNING PATIENT SAMPLES ON THE INSTRUMENT AND OBTAINED ADDITIONAL DISCORDANT NA, K, AND CL RESULTS ON THE PATIENT SAMPLES. A SIEMENS HEADQUARTERS SUPPORT CENTER SPECIALIST REVIEWED INSTRUMENT DATA AND DETERMINED THAT THE DISCORDANT RESULTS HAD BEEN OBTAINED ON MULTIPLE PATIENT SAMPLES RUN IN THE TIMEFRAME OF (B)(6) 2016. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON THE SAME INSTRUMENT, RESULTING HIGHER EXCEPT FOR SODIUM RESULT OF (B)(6), WHICH RESULTED LOWER THAN THE INITIAL RESULT. THE CUSTOMER ALSO REPEATED THE SAMPLES ON AN ALTERNATE DIMENSION EXL INSTRUMENT, MATCHING THE REPEAT RESULTS OBTAINED ON THE ORIGINAL INSTRUMENT (S/N: (B)(4)). IT IS UNKNOWN IF THE REPEAT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT SODIUM, CHLORIDE AND POTASSIUM RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316337 DIMENSION EXL WITH LM CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION EXL WITH LM

    Patients

    Seq Age Sex Outcome Treatment
    1