BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYCOPHENOLIC ACID

    MDR report key: 15089564 · Received July 22, 2022

    Report

    Report Number
    1823260-2022-02172
    Event Type
    Malfunction
    Date Received
    July 22, 2022
    Date of Event
    June 24, 2022
    Report Date
    September 14, 2022
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    OAV
    UDI-DI
    04015630997381
    PMA / PMN Number
    K063520
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    QUALITY CONTROLS ARE WITHIN RANGE EXCEPT THE FIRST LEVEL OF CONTROL DRIFTS UPWARD. NO LEVEL 1 CONTROL INFORMATION WAS AVAILABLE FOR THE TIME OF THE INCIDENT. THE LAST 10 CALIBRATIONS WERE STABLE. THE PATIENT'S FLUCONAZOLE MEDICATION DOES NOT INTERFERE WITH THE ASSAY AND INTERFERENCE WITH THE PIRACETAM MEDICATION IS UNLIKELY. THE INVESTIGATION DETERMINED THAT THE ISSUE IS CONSISTENT WITH HIGH DIURESIS AND HIGH AMOUNTS OF HERBAL INFUSION. A PRODUCT PROBLEM CAN MOST LIKELY BE EXCLUDED.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED A QUESTIONABLE RESULT FOR ONE PATIENT SAMPLE TESTED WITH MPA MYCOPHENOLIC ACID ON A COBAS 6000 C (501) MODULE (SERIAL NUMBER (B)(4). THE SAMPLE VALUE DID NOT CORRESPOND TO THE PATIENT'S CONDITION. THE SAMPLE RESULTED IN A MYCOPHENOLIC ACID VALUE OF 2.37 UG/ML WHEN TESTED ON THE C501 ANALYZER. THE VALUE WAS REPORTED OUTSIDE OF THE LABORATORY TO THE PATIENT'S DOCTOR. THE VALUE DID NOT AGREE WITH THE PATIENT'S CONDITION. THE SAMPLE WAS SENT TO A SECOND SITE WHERE IT WAS TESTED USING AN UNKNOWN METHOD ON A SIEMENS ANALYZER AND THE RESULT WAS SIMILAR TO THE ONE OBTAINED ON THE C501 ANALYZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546968 MYCOPHENOLIC ACID MYCOPHENOLIC ACID TEST SYSTEM OAV ROCHE DIAGNOSTICS NA 570241 04015630997381

    Patients

    Seq Age Sex Outcome Treatment
    1 Male CELLCEPT| FLUCONAZOLE (3 TIMES WEEKLY)| HERBAL INFUSIONS| PIRACETAM (TWICE DAILY)