BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VANCOMYCIN

    MDR report key: 8732552 · Received June 25, 2019

    Report

    Report Number
    1823260-2019-02299
    Event Type
    Malfunction
    Date Received
    June 25, 2019
    Date of Event
    May 18, 2019
    Report Date
    August 8, 2019
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LEH
    PMA / PMN Number
    K060586
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    UPON INVESTIGATION OF THE PATIENT SAMPLES, IT WAS DETERMINED THAT THE SAMPLES CONTAIN AN INTERFERING SUBSTANCE WHICH INCREASES THE KINETICS OF THE AGGLUTINATION REACTION. FURTHER ANALYSIS OF THE SAMPLES BY SERUM ELECTROPHORESIS AND IMMUNFIXATION POINT TOWARD THE PRESENCE OF A MONO- OR BI-CLONAL LGM GAMMOPATHY OF A LAMBDA TYPE. PER PRODUCT LABELING, "IN VERY RARE CASES, GAMMOPATHY, IN PARTICULAR TYPE IGM (WALDENSTRÖM¿S MACROGLOBULINEMIA), MAY CAUSE UNRELIABLE RESULTS."

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). THE 4 SAMPLES FROM THE PATIENT WERE SUBMITTED FOR INVESTIGATION. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THE INITIAL REPORTER COMPLAINED OF DISCREPANT LOW RESULTS FOR 4 SAMPLES FROM 1 PATIENT TESTED FOR ONLINE RDM VANCOMYCIN GEN. 3 (VANC3) ON A COBAS 8000 C 502 MODULE COMPARED TO THE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (HPLC) METHOD AND THE ARCHITECT METHOD. THE PATIENT WAS IN THE HOSPITAL WITH A LUNG INFECTION WITH AN OXACILLIN RESISTANT S. AUREUS AND WAS ALREADY BEING TREATED WITH VANCOMYCIN. THE LOW RESULTS FROM THE C502 MODULE WERE REPORTED OUTSIDE OF THE LABORATORY WHERE THE PHYSICIAN INCREASED THE PATIENT'S VANCOMYCIN DOSAGE BASED ON THE RESULTS. THE PATIENT'S HEALTH WAS NOT NEGATIVELY AFFECTED BY THE HIGHER DOSAGE. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED DUE TO THE DEVICE RESULTS. THE C502 MODULE SERIAL NUMBER WAS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525986 VANCOMYCIN RADIOIMMUNOASSAY, VANCOMYCIN LEH ROCHE DIAGNOSTICS NA 391254

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR