BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMBUR 10 UX 100

    MDR report key: 9466460 · Received December 13, 2019

    Report

    Report Number
    1823260-2019-04412
    Event Type
    Malfunction
    Date Received
    December 13, 2019
    Date of Event
    November 22, 2019
    Report Date
    July 29, 2020
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JIL
    PMA / PMN Number
    K032437
    Removal / Correction Number
    RES81177
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER DID NOT RETURN ANY PRODUCT. THE SUSPECT MEDICAL DEVICE HAS BEEN UPDATED. APPLICABLE FIELDS OF SECTIONS D AND G WERE UPDATED. THE (B)(6) ANALYZER SERIAL NUMBER WAS (B)(6). SECTION H9 WAS UPDATED. DURING INTERNAL TESTING, ROCHE DETERMINED THE LIMITS OF DETECTION (LOD) FOR PROTEIN, NITRITE, LEUKOCYTES, AND ERYTHROCYTES ON THE (B)(6) URINE ANALYZER WITH CHEMSTRIP® 5 OB, CHEMSTRIP 7, CHEMSTRIP 10 MD, AND CHEMSTRIP 10 UA TEST STRIPS WERE HIGHER THAN WHAT IS LISTED IN THEIR RESPECTIVE TEST STRIP METHOD SHEETS. THIS CAN LEAD TO FALSE NEGATIVE RESULTS ON THE (B)(6) URINE ANALYZER FOR THE FOUR AFFECTED PARAMETERS. ROCHE HAS PROVIDED CUSTOMERS WITH THE FOLLOWING INSTRUCTIONS AND WORK AROUNDS: CHEMSTRIP 5 OB AND CHEMSTRIP 7 TEST STRIPS SHOULD ONLY BE READ VISUALLY. THEY CAN NO LONGER BE READ ON THE (B)(6)URINE ANALYZER. CHEMSTRIP 10 MD OR CHEMSTRIP 10 UA TEST STRIPS CAN BE USED WITH THE (B)(6) URINE ANALYZER; HOWEVER, A NEGATIVE RESULT FOR ANY ONE OF THE FOUR AFFECTED PARAMETERS (I.E., PROTEIN, NITRITE, LEUKOCYTES, AND ERYTHROCYTES) ON THE (B)(6) URINE ANALYZER MUST BE REPEATED WITH A NEW TEST STRIP THAT IS READ VISUALLY.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). THE ANALYZER HAS BEEN USED SINCE THIS EVENT AND ALL RESULTS HAVE BEEN ACCURATE. QC HAD PASSED.

    Description of Event or Problem · 1

    THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT TESTED FOR LEUKOCYTES ON A URISYS 1100 ANALYZER. THE RESULT FROM THE INSTRUMENT WAS NEGATIVE. WHEN THEY CHECKED VISUALLY THE RESULT WAS POSITIVE (500 LEUKOCYTES). THE COMBUR 10 TEST STRIP LOT NUMBER WAS 38055304 WITH AN EXPIRATION DATE OF 31-MAR-2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1264090 COMBUR 10 UX 100 URINE TEST STRIPS JIL ROCHE DIAGNOSTICS U1100 38055304

    Patients

    Seq Age Sex Outcome Treatment
    1