BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONLINE TDM VANCOMYCIN GEN.3

    MDR report key: 14240668 · Received April 28, 2022

    Report

    Report Number
    1823260-2022-01214
    Event Type
    Malfunction
    Date Received
    April 28, 2022
    Date of Event
    April 7, 2022
    Report Date
    June 9, 2022
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LEH
    UDI-DI
    07613336157800
    PMA / PMN Number
    K152245
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE ENGINEER CHECKED PROBE ALIGNMENTS, PROBE WASHES, PUMP PRESSURES, AND RINSE LEVELS TO ENSURE PROPER OPERATION. THE CUSTOMER RAN CALIBRATION AND CONTROLS; ALL VALUES WERE WITHIN THE CUSTOMER'S SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

    INVESTIGATIONS HAVE DETERMINED THAT CALIBRATION FREQUENCY SPECIFICATIONS WERE NOT MET FOR THE VANCOMYCIN ASSAY. THERE WAS A DOWNWARD DRIFT IN MEASUREMENT SIGNALS FOR THE REAGENT PACK IN USE. THIS LEADS TO A HIGHER RECOVERY IN QUALITY CONTROLS AND PATIENT SAMPLES FOR THE REAGENT PACK IN USE. NOTIFICATIONS HAVE BEEN SENT TO CUSTOMERS ALERTING THEM OF THIS ISSUE. IT IS RECOMMENDED TO CUSTOMERS TO CAREFULLY MONITOR CONTROL INTERVALS AND RECOVERY.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY HAVE BEEN HAVING ISSUES WITH VANC3 VANCOMYCIN RECOVERY ON THE COBAS PRO C 503 ANALYTICAL UNIT. CONTROL RECOVERY WILL GO HIGHER AND THEN THEY HAVE TO RECALIBRATE. AFTER RECALIBRATING, THE CUSTOMER WILL PULL PATIENT SAMPLES THAT WERE PREVIOUSLY TESTED AND REPEAT THESE. THE REPORTER PROVIDED DATA FOR ONE PATIENT SAMPLE THAT HAD DISCREPANT VANCOMYCIN RESULTS. THE SAMPLE INITIALLY RESULTED IN A VANCOMYCIN VALUE OF 48.8 UG/ML AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS PULLED AND REPEATED AFTER CONTROLS WENT HIGH AND THE ASSAY WAS RECALIBRATED. THE REPEAT RESULT WAS 38 UG/ML ON (B)(6) 2022. THE REPEAT VALUE WAS DEEMED CORRECT AND A CORRECTED REPORT WAS ISSUED. THE SERIAL NUMBER OF THE C 503 ANALYZER IS 2190-03.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105180 ONLINE TDM VANCOMYCIN GEN.3 VANCOMYCIN IMMUNOASSAY LEH ROCHE DIAGNOSTICS NA ASKU 07613336157800

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown