BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    COMBUR-9-TEST 50STR.

    MDR report key: 9615419 · Received January 22, 2020

    Report

    Report Number
    1823260-2020-90013
    Event Type
    Malfunction
    Date Received
    January 22, 2020
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JMT
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOR THE EVENT, THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE CUSTOMER RETURNED STRIP LOT 38054701. THE RETENTION MATERIAL OF LOT 38054700 AND THE CUSTOMER MATERIAL OF LOT 38054701 WERE VISUALLY CHECKED. THE CUSTOMER VIAL WAS ALSO TESTED FOR TIGHTNESS. THE RETENTION MATERIAL SHOWS NO DISCOLORATIONS OR ABNORMALITIES. THE CUSTOMER MATERIAL SHOWED DISCOLORATIONS ON THE NITRITE TEST PAD. THE TEST FOR TIGHTNESS WAS PASSED.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOR THE EVENT IS STILL ONGOING. FOLLOW UP ACTIONS INCLUDE: THE CUSTOMER MATERIAL OF LOT 38054701 WAS PROVIDED FOR INVESTIGATION. THE RETENTION MATERIAL OF LOT 38054700 AND THE CUSTOMER MATERIAL OF LOT 38054701 WERE VISUALLY CHECKED. THE RETENTION MATERIAL SHOWED NO DISCOLORATIONS OR ABNORMALITIES. THE CUSTOMER MATERIAL SHOWS DISCOLORATIONS ON THE NITRITE, PROTEIN , KETONE , UROBILINOGEN, AND BILIRUBIN TEST PADS. THE CUSTOMER'S TEST STRIP VIAL WAS CHECKED FOR TIGHTNESS AND THIS CHECK PASSED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING. THERE WERE NO FOLLOW UP ACTIONS FOR THE EVENT. NO DEVICES WERE RETURNED. THIS DEVICE IS NOT LABELED FOR SINGLE USE AND IS NOT REPROCESSED OR REUSED.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES <NOE>1</NOE> MALFUNCTION EVENT. QUESTIONABLE HIGH RESULTS WERE GENERATED BY THE COMBUR 9 TEST STRIPS. THE EVENTS INVOLVED AN UNSPECIFIED NUMBER OF PATIENTS TESTED FOR NITRITES. THE PATIENTS' AGES WERE REQUESTED, BUT WERE NOT PROVIDED. THE PATIENTS' WEIGHTS WERE REQUESTED, BUT WERE NOT PROVIDED. THE PATIENTS' GENDERS WERE REQUESTED, BUT WERE NOT PROVIDED. THE PATIENTS' RACES WERE REQUESTED, BUT WERE NOT PROVIDED. THE PATIENTS' ETHNICITIES WERE REQUESTED, BUT WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82762 COMBUR-9-TEST 50STR. URINE TEST STRIPS JMT ROCHE DIAGNOSTICS COMBUR 9 38054701

    Patients

    Seq Age Sex Outcome Treatment
    1