BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA CH 930 ANALYZER

    MDR report key: 10358999 · Received August 3, 2020

    Report

    Report Number
    2432235-2020-00357
    Event Type
    Malfunction
    Date Received
    August 3, 2020
    Date of Event
    July 10, 2020
    Report Date
    August 3, 2020
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    UDI-DI
    00630414002439
    PMA / PMN Number
    K151767
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC). SIEMENS DISPATCHED A CUSTOMER SERVICE ENGINEER (CSE) TO THE CUSTOMER SITE. THE SIEMENS CSE EVALUATED THE EVENT AND NOTED THE LOW RECOVERY IS DUE TO A USE ERROR. ON (B)(6) 2020, THE CALIBRATOR GAVE A HIGH ABSORBANCE OF 636 MAU. ON (B)(6) 2020, THE PACK CALIBRATION ON WELL 1 WAS PERFORMED, AND THE CALIBRATOR GAVE AN ABSORBANCE OF 387 MAU. ON (B)(6) 2020, THE USE OF WELL 2 STARTED, AND THE PACK CALIBRATION FROM (B)(6) 2020 WAS USED. ON (B)(6) 2020, AFTER RESTARTING THE PROCESS CONTROL COMPUTER (PCC), GLUCOSE HEXOKINASE_3 (GLUH_3) WAS REVERTED TO THE LOT CALIBRATION FROM 15-JUNE-2020 AND PRODUCED THE LOW RESULTS REPORTED. THE CUSTOMER ALLEGED THAT NO OTHER METHODS WERE AFFECTED. THE CUSTOMER USED A NEW PACK AND PERFORMED A RECALIBRATION, AND CORRECTED THE LOW RECOVERY. THE ANALYZER HAS PERFORMED ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE WAS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT, FALSELY DEPRESSED, GLUCOSE HEXOKINASE_3 (GLUH_3) RESULTS WERE OBTAINED ON THE ATELLICA CH 930 ANALYZER. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE CUSTOMER USED AN INCORRECT CALIBRATION AND PERFORMED A NEW CALIBRATION, RAN QUALITY CONTROL TESTING, AND USED THE SAME SAMPLES TO PERFORM REPEAT TESTING ON THE SAME INSTRUMENT. THE CUSTOMER INFORMED THAT CORRECTED REPORTS WERE ISSUED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSE DEPRESSED GLUH_3 RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823152 ATELLICA CH 930 ANALYZER ATELLICA CH 930 ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CH 930 ANALYZER 00630414002439

    Patients

    Seq Age Sex Outcome Treatment
    1