BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMBUR10 TEST M

    MDR report key: 14083155 · Received April 12, 2022

    Report

    Report Number
    1823260-2022-01001
    Event Type
    Malfunction
    Date Received
    April 12, 2022
    Date of Event
    March 16, 2022
    Report Date
    May 2, 2022
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LJX
    PMA / PMN Number
    K032437
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FOR PATIENT 1, A BACTERIOGRAM WAS PERFORMED AND GRAM POSITIVE COCCI BACTERIUM WAS IDENTIFIED BUT IT DID NOT GROW IN CYSTEINE-LACTOSE-ELECTROLYTE-DEFICIENT (CLED) AGAR. THE TEST STRIPS WERE REQUESTED FOR INVESTIGATION. HOWEVER; THE PRODUCT IS NOT EXPECTED FOR RETURN. THE RETENTION MATERIAL OF LOT 55017400 WAS MEASURED ON A URISYS 1100 ANALYZER AT THE INVESTIGATION SITE WITH 0-NATIVE-URINE AND A LEUKOCYTES-DILUTION-SERIES. NEITHER FALSE POSITIVE NOR FALSE NEGATIVE RESULTS WERE OBSERVED. THE RETENTION MATERIAL FULFILLS THE REQUIREMENTS. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    THE INITIAL REPORTER COMPLAINED OF QUESTIONABLE NEGATIVE RESULTS FOR 2 PATIENTS TESTED FOR LEUKOCYTES WITH COMBUR10 TEST M URINE TEST STRIPS ON A URISYS 1100 INSTRUMENT. PATIENT 1 INITIAL RESULT WAS NEGATIVE. THE 2ND RESULT WAS 500 LEU/UL. PATIENT 2 INITIAL RESULT WAS NEGATIVE. THE 2ND RESULT WAS 100 LEU/UL. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE HIGHER RESULTS WERE BELIEVED TO BE CORRECT. THE URISYS 1100 INSTRUMENT SERIAL NUMBER WAS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209434 COMBUR10 TEST M METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE) LJX ROCHE DIAGNOSTICS NA 55017404

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Female PATIENT 2 ¿ EMPAGLIFLOZIN| PATIENT 2 ¿ METFORMIN HYDROCHLORIDE