BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CHEMISTRY

    MDR report key: 19125037 · Received April 17, 2024

    Report

    Report Number
    2432235-2024-00068
    Event Type
    Malfunction
    Date Received
    April 17, 2024
    Date of Event
    April 8, 2024
    Report Date
    June 5, 2024
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    KLB
    UDI-DI
    00630414561677
    PMA / PMN Number
    K003341
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION (29-MAY-2024): 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 INSTRUMENT DATA SHOWED THAT THE CALIBRATION WAS ACCEPTABLE AND QUALITY CONTROL (QC) RECOVERY WAS WITHIN THE CUSTOMER¿S EXPECTED RANGES. THE CUSTOMER PERFORMED A QC PRECISION STUDY, AND THE RESULTS OBTAINED WERE WITHIN THE CUSTOMER¿S EXPECTED RANGES. THE TOBRAMYCIN_2 (TOB_2) ASSAY AND THE ADVIA CHEMISTRY XPT SYSTEM WERE PERFORMING ACCEPTABLY, AND THE ISSUE WAS RESOLVED BY REPROCESSING THE SAME SAMPLE. THE CAUSE OF THE EVENT IS UNKNOWN. THE CUSTOMER IS OPERATIONAL. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED. SECTION H6 HAS BEEN UPDATED TO REFLECT THE HSC INVESTIGATION. INITIAL MDR 2432235-2024-00068 WAS FILED ON 17-APR-2024.

    Additional Manufacturer Narrative · 0

    AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS CUSTOMER CARE CENTER (CCC) REGARDING AN ERRONEOUSLY ELEVATED TOBRAMYCIN_2 (TOB_2) RESULT ON A NEONATAL PATIENT SAMPLE OBTAINED ON AN ADVIA CHEMISTRY XPT SYSTEM. SIEMENS IS INVESTIGATING THE EVENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED AN ERRONEOUSLY ELEVATED TOBRAMYCIN_2 (TOB_2) RESULT ON A NEONATAL PATIENT SAMPLE ON AN ADVIA CHEMISTRY XPT SYSTEM. THE ERRONEOUSLY ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN(S), AND THE RESULT WAS QUESTIONED. THE SAME SAMPLE WAS REPROCESSED ON THE ORIGINAL ADVIA CHEMISTRY XPT SYSTEM. ALSO, A NEW SAMPLE WAS DRAWN FROM THE SAME PATIENT AND PROCESSED ON THE ORIGINAL ADVIA CHEMISTRY XPT SYSTEM. LOWER RESULTS WERE OBTAINED, CONSIDERED CORRECT, AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED TOBRAMYCIN_2 (TOB_2) RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1340330 ADVIA CHEMISTRY ADVIA CHEMISTRY TOB_2 REAGENTS (4 X 100 TESTS) KLB SIEMENS HEALTHCARE DIAGNOSTICS INC. N/A 170 00630414561677

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Unknown