BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA CH 930 ANALYZER

    MDR report key: 11808734 · Received May 11, 2021

    Report

    Report Number
    2432235-2021-00119
    Event Type
    Malfunction
    Date Received
    May 11, 2021
    Date of Event
    October 20, 2020
    Report Date
    May 11, 2021
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    UDI-DI
    00630414002163
    PMA / PMN Number
    K151767
    Removal / Correction Number
    2432235-05/11/2021-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS INVESTIGATED COMPLAINTS REGARDING THE ISSUE WHERE THE PHOTOMETER LAMP UNEXPECTEDLY INCREASES IN INTENSITY ON ONE OR MORE OF THE ELEVEN WAVELENGTHS USED IN TESTING. SIEMENS DETERMINED THAT DISCREPANT RESULTS MAY BE GENERATED IF THE ISSUE OCCURS. IF THE PHOTOMETER LAMP DOES REACH SATURATION ON ANY OF THE WAVELENGTHS USED FOR TESTING, THE ANALYZER WILL POST EVENT CODE "04 474 04 58", IN THE OPERATOR EVENT LOG, WITH THE MESSAGE, "PHOTOMETER LAMP INTENSITY IS LOW ON AT LEAST 1 WAVELENGTH. PERFORM THE LAMP REPLACEMENT ROUTINE IN OPERATOR DIAGNOSTICS". ALONG WITH THE EVENT CODE AN ALERT IS POSTED TO THE OPERATOR IN THE MODULE STATUS SCREEN WITH A RED TRIANGLE. THE OPERATOR EVENT CODES AND ALERTS WILL BE GENERATED IF THE LAMP INTENSITY GOES ABOVE OR BELOW THE ACCEPTABLE INTENSITY RANGE ON ANY WAVELENGTH. RESULTS GENERATED AFTER THE EVENT CODE AND ALERT WILL NOT BE FLAGGED IF THE LAMP INTENSITY WAS ABOVE THE ACCEPTABLE INTENSITY RANGE. RESULTS GENERATED AFTER THE EVENT CODE AND ALERT WILL BE FLAGGED WITH, "MEASUREMENT ERROR", AND A NUMERIC VALUE WILL NOT BE CALCULATED, IF THE LAMP INTENSITY WAS BELOW THE ACCEPTABLE INTENSITY RANGE. THE EVENT CODE WILL REPEAT EVERY HOUR UNTIL THE LAMP IS REPLACED AND ALL WAVELENGTHS RESTORED TO THEIR RESPECTIVE INTENSITY RANGES. LAMP INTENSITY IS MEASURED WHILE THE SYSTEM IS IDLE IN STANDBY MODE, AS WELL AS WHEN THE ANALYZER IS PROCESSING SAMPLES. IF THE USER CHECKS THE OPERATOR EVENT LOG AND ALERTS AND REPLACES THE LAMP BEFORE PROCESSING SAMPLES, THERE IS NO POTENTIAL FOR ERRONEOUS RESULTS. AN URGENT MEDICAL DEVICE CORRECTION (UMDC) ASI21-03.A.US WAS SENT TO US CUSTOMERS AND AN URGENT FIELD SAFETY NOTICE (UFSN) ASI21-03.A.OUS WAS SENT TO OUTSIDE THE US (OUS) CUSTOMERS IN MAY OF 2021. THE UMDC AND UFSN EXPLAIN THE BEHAVIOR DESCRIBED ABOVE AND REQUESTS CUSTOMERS TO FOLLOW THE INSTRUCTIONS OF THE UMDC/UFSN TO ENSURE CORRECT OPERATION OF THE SYSTEMS. THE UMDC AND UFSN DELINEATE THAT SOFTWARE V1.25 OR HIGHER WILL BE RELEASED SOON TO RESOLVE THESE BEHAVIORS. TO DATE, THERE ARE NO ALLEGATIONS OF INJURY DUE TO THIS BEHAVIOR.

    Description of Event or Problem · 1

    SIX DISCORDANT, FALSELY ELEVATED CREATININE_2 (CREA_2) PATIENT RESULTS WERE OBTAINED ON AN ATELLICA CH 930 INSTRUMENT. THE DISCORDANT RESULTS WERE REPORTED TO AND QUESTIONED BY THE PHYSICIAN(S). THE SAME SAMPLES WERE REPEATED ON AN ALTERNATE ATELLICA CH 930 INSTRUMENT. THE REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). AT THE TIME OF THE ISSUE, THE CUSTOMER DISCOVERED THAT THE PHOTOMETER LAMP INTENSITY WAS LOW. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, CREATINE_2 RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703056 ATELLICA CH 930 ANALYZER ATELLICA CH 930 ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CH 930 ANALYZER 00630414002163

    Patients

    Seq Age Sex Outcome Treatment
    1