BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMBUR-10-M 100 STR

    MDR report key: 8951347 · Received August 30, 2019

    Report

    Report Number
    1823260-2019-03187
    Event Type
    Malfunction
    Date Received
    August 30, 2019
    Date of Event
    August 13, 2019
    Report Date
    August 30, 2019
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JMT
    PMA / PMN Number
    K032437
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). THE TEST STRIPS WERE REQUESTED FOR INVESTIGATION. THE PRODUCT HAS NOT BEEN RECEIVED AT THIS TIME. IF THE PRODUCT IS RETURNED IN THE FUTURE, A FOLLOW UP REPORT WILL BE SUBMITTED. THE RETENTION MATERIAL OF LOT 38908000 WAS VISUALLY CHECKED AND TESTED WITH A NITRITE-DILUTION-SERIES AND 0-NATIVE-URINE. THE RETENTION MATERIAL SHOWED NO FALSE POSITIVE RESULTS AND FULFILL THE REQUIREMENTS. THE INVESTIGATION STATED THE TEST STRIP VIAL STOPPER CONTAINS A DRYING AGENT AND WAS TESTED TO BE SUFFICIENT UNTIL ALL STRIPS ARE USED UP IF THE USER RE-CAPS THE VIAL RIGHT AFTER REMOVING A STRIP. THERE HAVE BEEN NO OTHER SIMILAR COMPLAINTS RECEIVED FOR THIS LOT NUMBER. A 100% TIGHTNESS CHECK IS PERFORMED ON EACH VIAL PRIOR TO LEAVING THE PRODUCTION LINE. THE ENGINEER AT THE CUSTOMER SITE FOUND THAT THE TEST STRIP PUSHER WAS CONTAMINATED WITH URINE. AFTER CLEANING THE TEST STRIP PUSHER, NEGATIVE QC RESULTS WERE BACK TO NORMAL AND WERE NEGATIVE. THIS SUGGESTS A HANDLING ISSUE AT THE CUSTOMER SITE. 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 COMPLAINED OF POSITIVE NITRITE RESULTS FOR "MANY" PATIENT SAMPLES TESTED WITH COMBUR-10 URINE TEST STRIPS. THE CUSTOMER ALLEGED THAT THE SEAL ON THE TEST STRIP VIAL WAS "NOT GOOD" CAUSING THE POSITIVE NITRITE RESULTS. THE CUSTOMER STATED THE SAMPLES WERE FRESH, WITH NO BACTERIA. NEGATIVE QC TESTS ALSO SHOWED AS POSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742892 COMBUR-10-M 100 STR URINE TEST STRIPS JMT ROCHE DIAGNOSTICS COMBUR-10-M 38908002

    Patients

    Seq Age Sex Outcome Treatment
    1