BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMBUR-10-M 100 STR

    MDR report key: 9190131 · Received October 15, 2019

    Report

    Report Number
    1823260-2019-03708
    Event Type
    Malfunction
    Date Received
    October 15, 2019
    Date of Event
    September 19, 2019
    Report Date
    October 15, 2019
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JMT
    PMA / PMN Number
    K032437
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). A VISUAL INSPECTION OF THE TEST STRIPS SHOWED THAT THE TEST STRIP PADS WERE DISCOLORED WHICH MAY INDICATE MISHANDLING OF THE TEST STRIPS. NORMAL QC WAS PERFORMED ON THE TEST STRIPS AND A POSITIVE NITRITE RESULT WAS ALSO RECEIVED. QC WAS RUN ON A NEW VIAL OF TEST STRIPS AND THE RESULTS WERE OK. THE CUSTOMER DOESN'T RUN QC ON A REGULAR BASIS. THE CUSTOMER HAS INSTALLED THE NEW SOFTWARE CHIP ON THE METER. THE TEST STRIPS WERE REQUESTED FOR INVESTIGATION, HOWEVER, THE CUSTOMER HAS DISCARDED THE TEST STRIPS. THE RETENTION MATERIAL OF LOT 39009700 WAS MEASURED ON AN INVESTIGATION UNIT COBAS U411 WITH 0-NATIVE-URINE, A NITRITE-DILUTION-SERIES, AND PROTEIN-DILUTION-SERIES AND A GLUCOSE-DILUTION-SERIES ACCORDING TO THE TESTING PLAN. THE MEASUREMENTS SHOWED NO FALSE POSITIVE RESULTS AND SHOWED NO ABNORMALITIES. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE INITIAL REPORTER QUESTIONED RESULTS FOR 1 PATIENT SAMPLE TESTED WITH COMBUR-10 URINE TEST STRIPS ON A URISYS 1100 ANALYZER SERIAL NUMBER (B)(4). BASED ON THE DATA PROVIDED, THE PATIENT HAD A FALSE POSITIVE NITRITE RESULT. THE RESULT FROM THE URISYS 1100 ANALYZER WAS POSITIVE. THE SAMPLE WAS SENT TO ANOTHER LABORATORY WHERE THE NITRITE RESULT FROM AN UNKNOWN METHOD WAS "0" (ZERO).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    984644 COMBUR-10-M 100 STR URINE TEST STRIPS JMT ROCHE DIAGNOSTICS COMBUR-10-M 38908002

    Patients

    Seq Age Sex Outcome Treatment
    1