BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONLINE TDM VANCOMYCIN GEN.3

    MDR report key: 12475904 · Received September 15, 2021

    Report

    Report Number
    1823260-2021-02693
    Event Type
    Malfunction
    Date Received
    September 15, 2021
    Date of Event
    August 21, 2021
    Report Date
    October 8, 2021
    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
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THE ALARM ACCOMPANYING THE INITIAL RESULT CORRECTLY ALERTED THE USER TO AN ISSUE WITH THE SAMPLE. FOR THE UNUSUAL REACTION KINETICS ALARM, PRODUCT LABELING STATES: "THERE IS A HIGH POSSIBILITY THAT THE SAMPLE CONTAINS AN INTERFERING SUBSTANCE WHICH ACCELERATES THE REACTION KINETICS. FOR SUCH SAMPLES IT IS NOT POSSIBLE TO REPORT A RELIABLE ANALYTE CONCENTRATION WITH THIS ASSAY. FOR DIAGNOSTIC PURPOSES, THE RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT¿S MEDICAL HISTORY, CLINICAL EXAMINATION AND OTHER FINDING." THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THERE WAS A COMPLAINT OF DISCREPANT VANCOMYCIN IMMUNOASSAY RESULTS FOR ONE PATIENT BETWEEN TWO COBAS 6000 C501 MODULE SERIAL NUMBERS (B)(4) AND A BM NANOPIA (SEKISUI) USING ONLINE TDM VANCOMYCIN GEN.3. ON (B)(6) 2021, THE INITIAL RESULTS GAVE AN UNKNOWN NUMERIC VALUE AND HAD AN ALARM INDICATING UNUSUAL REACTION KINETICS. THE SAMPLE WAS CENTRIFUGED AND THE SAME RESULT WAS OBTAINED; THE NUMERICAL RESULT WAS REQUESTED BUT NOT PROVIDED. THE SAMPLE WAS DILUTED AND RESULTED IN THE ALARM INDICATING UNUSUAL REACTION KINETICS. THE RESULTS WERE THE SAME FOR BOTH COBAS 6000 C501 MODULES. ON (B)(6) 2021, THE SAMPLE WAS REPEATED ON A COBAS AND PRODUCED A RESULT OF 4.8 UG/ML. ON (B)(6) 2021, THE CUSTOMER TOOK A NEW BLOOD SAMPLE FROM THE PATIENT AND RAN THE NEW SAMPLE. THE RESULT WAS 4.8 UG/ML ON THE COBAS C501. THE RESULT WAS AROUND 19-20 UG/ML ON THE BM NANOPIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1370112 ONLINE TDM VANCOMYCIN GEN.3 VANCOMYCIN IMMUNOASSAY LEH ROCHE DIAGNOSTICS NA 450529 07613336157800

    Patients

    Seq Age Sex Outcome Treatment
    1