BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION XPAND PLUS WITH HM

    MDR report key: 6271558 · Received January 23, 2017

    Report

    Report Number
    2517506-2017-00042
    Event Type
    Malfunction
    Date Received
    January 23, 2017
    Date of Event
    December 29, 2016
    Report Date
    January 23, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGANOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K112999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC) REGARDING LOW SODIUM (NA) RESULTS OBTAINED ON PATIENT SAMPLES. CCC INSTRUCTED THE CUSTOMER TO BLEACH THE SYSTEM AND REPLACE THE SENSOR. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS AT THE CUSTOMER SITE. AFTER EVALUATING THE INSTRUMENT, THE CSE REPLACED THE ROTARY VALVE X-SEAL, THE XO TUBING, AND VERIFIED THAT FLUSH FLUID IN DRAIN WAS CLEAR OF BUBBLES, AFTER WHICH HE FOUND NONE. THE PERISTALTIC PUMP TUBING HAD BEEN REPLACED EARLIER BECAUSE THE PUMP RATE WAS TOO LOW. THE CSE PERFORMED DILUTION CHECK, WHICH PASSED. THE CSE REPLACED STANDARD A WITH A NEW ONE. THE CSE RAN PRECISION, RESULTING UNSATISFACTORY. THE CSE REPLACED THE SAMPLE PUMP TUBING AND SAMPLE PROBE AS THE TUBING WAS CRACKED. THE CSE ALIGNED AND PRIMED THE SYSTEM. THE CSE RAN SYSTEM CHECK AND PRECISION ON PATIENT SAMPLES, RESULTING SATISFACTORY. THE CSE RAN QUALITY CONTROLS (QC), RESULTING WITHIN SPECIFICATIONS. A SIEMENS HEADQUARTER SUPPORT CENTER (HSC) SPECIALIST REVIEWED THE INSTRUMENT DATA AND COULD NOT DETERMINE THE CAUSE OF EVENT. THE CAUSE OF THE DISCORDANT, FALSELY LOW NA 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, FALSELY LOW SODIUM (NA) RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES ON A DIMENSION XPAND PLUS WITH HM INSTRUMENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON THE SAME INSTRUMENT, RESULTING HIGHER. 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 NA RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53812 DIMENSION XPAND PLUS WITH HM CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGANOSTICS INC. DIMENSION XPAND PLUS WITH HM

    Patients

    Seq Age Sex Outcome Treatment
    1