BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CHEMISTRY XPT

    MDR report key: 9337567 · Received November 18, 2019

    Report

    Report Number
    2432235-2019-00421
    Event Type
    Malfunction
    Date Received
    November 18, 2019
    Date of Event
    October 29, 2019
    Report Date
    December 16, 2019
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    JJE
    UDI-DI
    00630414595467
    PMA / PMN Number
    K990346
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS FILED AN INITIAL MDR 2432235-2019-00421 ON 18-NOV-2019 FOR A DISCORDANT, FALSELY ELEVATED TOBRAMYCIN_2 PATIENT RESULT. ADDITIONAL INFORMATION (21-NOV-2019): SIEMENS WAS INFORMED THAT THE PHYSICIAN WAS EXPECTING A RESULT OF < 0.5 UG/ML ADDITIONAL INFORMATION (04-DEC-2019): SIEMENS HAS REVIEWED THE INFORMATION PROVIDED. THE CUSTOMER INITIALLY RECOVERED A RESULT (K) FLAG WHICH IS CONSISTENT WITH A RESULT BELOW THE CALIBRATOR LOW RANGE (<0.4 UG/ML). THE ORIGINAL SAMPLE WAS REPEATED AND RECOVERED A DISCORDANT VALUE OF 2.5 UG/ML. ADDITIONAL REPEATS RECOVERED VALUES CONSISTENT WITH THE ORIGINAL RESULT. CALIBRATION WAS WITHIN CONFORMANCE AND QUALITY CONTROL (QC) RESULTS RECOVERED WITHIN THE CUSTOMER ESTABLISHED RANGES. A REVIEWED OF THE INSTRUMENT PRINTOUTS AND INSTRUMENT FILTER-DATA ASSOCIATED WITH THE DISCORDANT RESULT INDICATED ELEVATED ABSORBANCE READINGS FOLLOWING REAGENT 1 AND SAMPLE ADDITION TO THE REACTION CUVETTE. POTENTIAL CAUSES MAY INCLUDE AN ATYPICAL REAGENT 1 OR SAMPLE ADDITION AS WELL AS PRE-ANALYTICAL SAMPLE HANDLING. A SERVICE ENGINEER WENT ON-SITE AND COMPLETED DILUTION PROBE PIPETTE (DDP) AND SAMPLE PROBE PIPETTE (SSP) ALIGNMENTS WHICH ARE A PART OF NORMAL TROUBLESHOOTING. THE CUSTOMER HAS NOT REPORTED ANY ADDITIONAL DISCORDANT TOBRAMYCIN_2 RESULTS. THE CUSTOMER IS OPERATIONAL. NO PRODUCT NON-CONFORMANCE WAS IDENTIFIED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC) TO REPORT A FALSELY ELEVATED TOBRAMYCIN_2 PATIENT RESULT. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) HAS VERIFIED THE DILUTION PROBE PIPETTE (DDP) AND SAMPLE PROBE PIPETTE (SSP) ALIGNMENTS TO THE CUVETTES. QUALITY CONTROL RESULTS WERE WITHIN ACCEPTABLE RANGES AT THE TIME OF THE EVENT. SIEMENS IS INVESTIGATING.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY ELEVATED TOBRAMYCIN_2 RESULT WAS OBTAINED UPON REPEAT ON A NEWBORN SAMPLE ON AN ADVIA CHEMISTRY XPT INSTRUMENT. THE PATIENT'S INITIAL TOBRAMYCIN RESULTED LOW (BELOW THE ASSAY MEASURING RANGE), SO THE CUSTOMER REPEATED THE SAME SAMPLE TWO MORE TIMES, RESULTING LOW. THE LOWER TOBRAMYCIN_2 RESULT WAS REPORTED TO THE PHYSICIAN(S) AS THE CORRECT RESULT. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED TOBRAMYCIN_2 RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1128501 ADVIA CHEMISTRY XPT IMMUNOASSAY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CHEMISTRY XPT 00630414595467

    Patients

    Seq Age Sex Outcome Treatment
    1 5 DA