BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMBUR 10 TEST

    MDR report key: 4943173 · Received July 27, 2015

    Report

    Report Number
    1823260-2015-03866
    Event Type
    Malfunction
    Date Received
    July 27, 2015
    Date of Event
    July 2, 2015
    Report Date
    September 15, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JIO
    PMA / PMN Number
    K032437
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL TEST STRIP SPECIFICATIONS HAVE BEEN MET FOR THE RETENTION SAMPLES TESTED. THE CUSTOMER HAS NOT MADE ANY FURTHER COMPLAINTS ABOUT THE STRIP LOT USED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF FALSE NEGATIVE ERYTHROCYTES (ERY) RESULTS FOR AN UNKNOWN NUMBER OF PATIENTS WHEN TESTED WITH "STUDY" COMBUR-10 URINE TEST STRIPS. THE CUSTOMER IS COMPARING THE COMBUR-10 URINE STRIPS TO SIEMENS MULTISTIX WHICH ARE TESTED ON THE SIEMENS CLINITEK 50 INSTRUMENT. THE ACTUAL RESULTS HAVE NOT BEEN PROVIDED. THIS INFORMATION HAS BEEN REQUESTED. THE DATE OF EVENT IS NOT KNOWN. IT IS NOT KNOWN IF THE RESULTS ARE BEING USED FOR DIAGNOSTIC PURPOSES. THIS INFORMATION HAS BEEN REQUESTED. IT IS NOT KNOWN IF ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. IT IS NOT KNOWN IF AN ADVERSE EVENT OCCURRED. NO ADVERSE EVENT WAS REPORTED. WHILE THE COMBUR-10 URINE STRIPS ARE NOT SOLD IN THE US, THE ROCHE URINE CHEMSTRIP IS SIMILAR. RETENTION SAMPLES OF THE SAME LOT THAT THE CUSTOMER USED WERE TESTED. THE REACTION COLORS WERE ACCEPTABLE AND DID NOT SHOW ANY ABNORMALITIES. NO FALSE NEGATIVE RESULTS WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486756 COMBUR 10 TEST BLOOD, OCCULT, COLORIMETRIC, IN URINE JIO ROCHE DIAGNOSTICS NA 22933001

    Patients

    Seq Age Sex Outcome Treatment
    1