BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 120/2120/2120I CN-FREE CBC TIMEPAC

    MDR report key: 16018710 · Received December 20, 2022

    Report

    Report Number
    2432235-2022-00393
    Event Type
    Malfunction
    Date Received
    December 20, 2022
    Date of Event
    November 24, 2022
    Report Date
    June 29, 2023
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    GKL
    PMA / PMN Number
    K971998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC). THE CUSTOMER REPORTED AN INCREASED INCIDENCE OF QUALITY CONTROLS (QC) FOR HEMOGLOBIN RECOVERING OUT OF RANGE FOR NORMAL QC. SIEMENS IS INVESTIGATING THE ISSUE. MDRS 2432235-2022-00394 AND 2432235-2022-00395 WERE FILED FOR LOTS: 18367 AND 36380 OF THE ADVIA 120/2120/2120I CN-FREE CBC TIMEPAC REAGENT, RESPECTIVELY.

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 2432235-2023-00393 ON 20-DEC-2022. ADDITIONAL INFORMATION (08-JUN-2023): THE INITIAL REPORT WAS CONSERVATIVELY FILED DUE TO THE CUSTOMER'S ALLEGATION OF POTENTIAL ERRONEOUS HEMOGLOBIN RESULTS DUE TO BLACK PARTICLES IN THE HEMOGLOBIN REAGENT. HOWEVER, AT THE TIME OF FILING, THE CUSTOMER DID NOT PROVIDE PATIENT RESULTS; AT THAT TIME, THE CUSTOMER PROVIDED EXAMPLES OF OUT-OF-RANGE QUALITY CONTROLS. SIEMENS FURTHER INVESTIGATED THE ISSUE AND DETERMINED THAT THE PARTICLES HAVE A PORE SIZE OF LESS THAN 105 MICRONS AND DOES NOT IMPACT PATIENT RESULTS NOR QUALITY CONTROLS. ADDITIONALLY, THESE PARTICLES WOULD NOT BLOCK ANY TUBES OR APERTURES IN THE SYSTEM AND WOULD FLOW THROUGH THE SYSTEM AND INTO THE WASTE CHAMBER. PARTICLES COULD POTENTIALLY ACCUMULATE OVER TIME AT JUNCTION POINTS IN THE FLUIDICS CIRCUIT. IN THE EVENT THAT PARTICLES ACCUMULATE AND RESULTS ARE PRODUCED, THE SYSTEM WOULD FLAG RESULTS WITH HGB IRREGULAR FLOW RATE (HGBIFR, HR), MAKING THIS APPARENT TO THE OPERATOR. SUPPLEMENTAL MDRS 2432235-2022-00394_S1 AND 2432235-2022-00395_S1 WERE ALSO FILED FOR THE ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED TINY BLACK PARTICLES IN THE HEMOGLOBIN (HGB) REAGENT OF THE ADVIA 120/2120/2120I CYANIDE FREE COMPLETE BLOOD COUNT TIMEPAC (ADVIA 120/2120/2120I CN-FREE CBC TIMEPAC), LOT: 65597. NONE OF THE OTHER REAGENTS IN THE ADVIA 120/2120/2120I CN-FREE CBC TIMEPAC HAVE THE PARTICLES. THE CUSTOMER INDICATED THAT INCORRECT HGB RESULTS MAY HAVE BEEN OBTAINED DUE TO THIS ISSUE, BUT NO PATIENT DATA WAS PROVIDED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2141452 ADVIA 120/2120/2120I CN-FREE CBC TIMEPAC ADVIA 120/2120/2120I CN-FREE CBC TIMEPAC GKL SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 120/2120/2120I CN-FREE CBC TIMEPAC 65597

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown