BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMBUR-10-M 100 STR

    MDR report key: 8711688 · Received June 19, 2019

    Report

    Report Number
    1823260-2019-02243
    Event Type
    Malfunction
    Date Received
    June 19, 2019
    Date of Event
    May 29, 2019
    Report Date
    September 10, 2019
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JMT
    PMA / PMN Number
    K032437
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EXPIRATION DATE WAS UPDATED. THE RETENTION MATERIAL, LOT 37378000, WAS MEASURED ON INVESTIGATION UNIT URISYS 1800 AND U 411 ANALYZER WITH 0-NATIVE URINE AND A NITRITE-DILUTION-SERIES AND WAS VISUALLY CHECKED. THE RESULTS OF THE MEASUREMENTS FULFILL THE REQUIREMENTS. NO FALSE POSITIVE RESULTS WERE OBSERVED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    AFTER CALIBRATION, THERE WERE NO MORE DISCREPANCIES WITH NITRITE RESULTS. THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE INITIAL REPORTER STATED THAT THEY HAVE RECEIVED DISCREPANT HIGH RESULTS FOR AN UNSPECIFIED NUMBER PATIENT SAMPLES TESTED FOR NITRITES ON A COBAS U 411 ANALYZER. NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPORTER STATED THAT THEY TESTED 142 URINE SAMPLES PER DAY OVER A 6 DAY PERIOD USING THE SAME TEST STRIP LOT NUMBER. WHEN TESTING THE SAMPLES ON THE U 411 ANALYZER, THE NITRITE RESULTS WILL BE POSITIVE. WHEN RUNNING TEST STRIPS MANUALLY ON THESE SAMPLES, THE VISUAL READING IS NEGATIVE FOR NITRITE. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENTS. THE SERIAL NUMBER OF THE U 411 ANALYZER IS (B)(4). THE REPORTER'S PRODUCT WAS REQUESTED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505344 COMBUR-10-M 100 STR URINE TEST STRIPS JMT ROCHE DIAGNOSTICS COMBUR-10-M 37378004

    Patients

    Seq Age Sex Outcome Treatment
    1