BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION XPAND PLUS WITHOUT HM

    MDR report key: 4182081 · Received October 17, 2014

    Report

    Report Number
    1226181-2014-00527
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 24, 2014
    Report Date
    September 24, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JJE
    PMA / PMN Number
    K112999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATION OF THE INSTRUMENT AND INSTRUMENT DATA, THE CSE CLEANED THE OPTICAL FILTERS, SOURCE LAMP LENS AND CUVETTE WINDOW. THE CSE REPLACED THE REAGENT 1, REAGENT 2 AND SAMPLE PROBE TIPS. THE CSE ADJUSTED ALIGNMENTS, THE CUVETTE TEMPERATURE FROM 37.6 TO 37.0, AND THE REAGENT FROM 1 TO 5. THE CSE REPLACED THE SOURCE LAMP, ALL SAMPLE AND REAGENT SYRINGES, VALVES AND TUBING. THE CSE PERFORMED PRECISION TESTING WHICH RESULTED WITHIN RANGE. THE CSE THEN RECALIBRATED HB1C WITH A NEW LOT, AND QC WAS BIASED LOW BUT WITHIN RANGE. THE CUSTOMER AND CSE WILL MONITOR THE INSTRUMENT FOR QC PERFORMANCE. THE CAUSE OF HB1C QC RESULTING OUT OF RANGE IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    THE OPERATOR OF A DIMENSION XPAND PLUS WITHOUT HM INSTRUMENT STATED THAT HEMOGLOBIN A1C (HB1C) QUALITY CONTROLS (QC) WERE HIGH, OUT OF RANGE. THE CUSTOMER STATED THAT A FEW LOW RESULTS WERE OBTAINED A DAY PRIOR TO QC ISSUES AND WERE REPORTED TO THE PHYSICIAN(S). THE RESULTS WERE NOT QUESTIONED AND THE CUSTOMER DID NOT PERFORM REPEAT TESTING. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE HB1C QC RESULTING OUT OF RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660978 DIMENSION XPAND PLUS WITHOUT HM CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION XPAND PLUS WITHOUT HM

    Patients

    Seq Age Sex Outcome Treatment
    1