BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMBUR-10-M 100 STR

    MDR report key: 9664089 · Received February 4, 2020

    Report

    Report Number
    1823260-2020-00286
    Event Type
    Malfunction
    Date Received
    February 4, 2020
    Date of Event
    January 13, 2020
    Report Date
    May 13, 2020
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JMT
    PMA / PMN Number
    K032437
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETENTION MATERIAL OF LOT 41516500 WAS MEASURED ON A RETENTION COBAS U411 AND ALSO CHECKED BY VISUAL READING WITH NATIVE URINE AND A NITRITE DILUTION SERIES. THE RETENTION MATERIAL SHOWED NO FALSE POSITIVE RESULTS AND FULFILLED REQUIREMENTS.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT NITRITE RESULTS FOR ONE PATIENT SAMPLE TESTED WITH COMBUR 10 M TEST STRIPS ON A COBAS U 411 ANALYZER. THE REPORTER SUSPECTS THE UROBERRY MEDICATION THE PATIENT WAS TAKING INTERFERED WITH THE TEST METHOD. THE SAMPLE INITIALLY RESULTED WITH A POSITIVE NITRITE VALUE ACCOMPANIED BY A DATA FLAG WHEN TESTED ON THE U 411 ANALYZER. THE SAMPLE WAS REPEATED ON THE U 411 ANALYZER, RESULTING WITH A NEGATIVE NITRITE VALUE. THE SAMPLE WAS ALSO TESTED MANUALLY USING A COMPETITOR URINE TEST STRIP (SPINREACT) AND THE NITRITE RESULT WAS POSITIVE. THE U 411 ANALYZER SERIAL NUMBER IS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126546 COMBUR-10-M 100 STR URINE TEST STRIPS JMT ROCHE DIAGNOSTICS COMBUR-10-M 41516505

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR UROBERRY