BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA®

    MDR report key: 6368411 · Received March 1, 2017

    Report

    Report Number
    9610806-2017-00036
    Event Type
    Malfunction
    Date Received
    March 1, 2017
    Date of Event
    July 1, 2016
    Report Date
    March 1, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    DCF
    PMA / PMN Number
    K061990
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE IMPRECISE URINE MALB RESULTS IS USER ERROR. STARTING WITH AN INCORRECT ENTRY OF THE METHOD CONFIGURATION DIGITS OF PRECISION SETTING IN (B)(6) 2016, THE QC AND PATIENT RESULTS HAD BEEN REPORTING WITH ONE DIGIT OF PRECISION CAUSING IMPRECISE VALUES. THE DIMENSION VISTA® SYSTEM OPERATOR'S GUIDE CHAPTER 9 ADVANCED FUNCTIONS > METHOD CONFIGURATION SECTION DESCRIBES THE SETTINGS FOR "FIXED DIGITS AFTER DECIMAL" AND "DIGITS OF PRECISION". THIS SETTING IS METHOD DEPENDENT. EXAMPLES ARE PROVIDED INDICATING HOW THE VALUE WOULD BE REPORTED DEPENDING ON THE SETTING CHOSEN. SUCH AS WITH THE MALB ISSUE REPORTED, IF "DIGITS OF PRECISION" IS SET TO 1, A RESULT OF 18 IS REPORTED AS 20. A NOTE IS ALSO LISTED: "IT IS RECOMMENDED THAT DIGITS OF PRECISION NOT BE CHANGED FROM THE DEFAULT SETTINGS IN THE SOFTWARE." QC VALUES REMAINED WITHIN LABORATORY RANGES DURING THE PERIOD OF INCORRECT SETTING. THE DIGITS OF PRECISION SETTING WAS CORRECTED (B)(6) 2017. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT IMPRECISE MICROALBUMIN (MALB) RESULTS WERE OBTAINED ON PATIENT AND QC URINE SAMPLES DURING A PERIOD IN WHICH AN INCORRECT DIGITS OF PRECISION SETTING HAD BEEN IN USE AT THE ACCOUNT. PATIENT RESULTS WERE REPORTED DURING THE PERIOD FROM JULY 2016 THROUGH THE BEGINNING OF FEBRUARY 2017. PATIENT RESULTS WERE REPORTED TO PHYSICIANS DURING THE PERIOD. THERE IS NO INDICATION THAT PHYSICIANS QUESTIONED THE RESULTS DURING THE PERIOD. THERE WAS NO KNOWN IMPACT ON PATIENT TREATMENT OR CARE AND NO ALLEGED PATIENT HARM DUE TO THE IMPRECISE MALB RESULTS DURING THIS PERIOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150503 DIMENSION VISTA® DIMENSION VISTA® MALB MICROALBUMIN FLEX® REAGENT CARTRIDGE DCF SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH 16134MA

    Patients

    Seq Age Sex Outcome Treatment
    1