BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA CH

    MDR report key: 20684269 · Received November 14, 2024

    Report

    Report Number
    2432235-2024-00295
    Event Type
    Malfunction
    Date Received
    November 14, 2024
    Date of Event
    October 10, 2024
    Report Date
    November 14, 2024
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    LEG
    UDI-DI
    630414596013
    PMA / PMN Number
    K982880
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS REMOTE SERVICES CENTER (RSC) REGARDING AN ERRONEOUSLY ELEVATED VALPROIC ACID (VPA) RESULT OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. SIEMENS HEALTHCARE DIAGNOSTICS HEADQUARTERS SUPPORT CENTER (HSC) CONCLUDED THE INVESTIGATION OF THE EVENT. HSC REVIEWED THE INSTRUMENT DATA FILES, AND THE INFORMATION PROVIDED BY THE CUSTOMER. THE CUSTOMER OBSERVED QUALITY CONTROL (QC) RECOVERING OUTSIDE OF THEIR EXPECTED RANGES BEFORE AND AFTER THE PATIENT SAMPLE TESTING. THE CUSTOMER REVIEWED THE VPA CALIBRATION CURVE (CAL ID 6615) AND OBSERVED THAT THE CALIBRATOR SHAPE WAS INCONSISTENT WITH HISTORICAL VPA CALIBRATOR CURVES. THE INTENDED CALIBRATION CURVE SHAPE IS IN INVERSE. THE CALIBRATION CURVE THAT GENERATED OUT OF RANGE QC RESULTS AND AN ERRONEOUSLY ELEVATED PATIENT SAMPLE RESULT WAS INCREASING IN SIGNAL WITH EACH CALIBRATOR LEVEL. THE CUSTOMER PERFORMED A NEW CALIBRATION WITH THE SAME VPA REAGENT LOT (140237) AND DRUG II CALIBRATOR, WHICH YIELDED AN ACCURATE CALIBRATION CURVE. HSC INDICATED THAT THE OPERATOR MISTAKENLY LOADED THE INCORRECT CALIBRATOR MATERIAL INTO THE APPROPRIATE BARCODE-LABELLED SAMPLE CONTAINER, CREATING AN INCREASING CALIBRATION CURVE. THE CALIBRATION CURVE WAS NOT INVESTIGATED UNTIL FUTURE QC FAILURES WERE OBSERVED USING THE SAME REAGENT LOT (140237). THE CAUSE OF THE EVENT IS CONSISTENT WITH A CALIBRATION CURVE FAILURE. THE CUSTOMER IS OPERATIONAL. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED AN ERRONEOUSLY ELEVATED VALPROIC ACID (VPA) RESULT ON A PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUSLY ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN(S), AND THE RESULT WAS QUESTIONED. THE SAME SAMPLE WAS REPROCESSED ON AN ALTERNATE ATELLICA CH 930 ANALYZER. A LOWER REPROCESSED RESULT WAS OBTAINED AND CONSIDERED CORRECT. A CORRECTED REPORT WAS ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED VALPROIC ACID (VPA) RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2197214 ATELLICA CH ATELLICA CH VALPROIC ACID (VPA) LEG SIEMENS HEALTHCARE DIAGNOSTICS INC. N/A 140237 630414596013

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female