BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URINE METER

    MDR report key: 6817004 · Received August 24, 2017

    Report

    Report Number
    3007966929-2017-00042
    Event Type
    Malfunction
    Date Received
    August 24, 2017
    Date of Event
    August 1, 2017
    Product Code
    FFG
    PMA / PMN Number
    EXEMPT
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THE FOLLOWING COMPLAINT ORIGINATED FROM (B)(6) HOSPITAL BUT WAS REPORTED VIA THE DISTRIBUTOR: (B)(4). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN REQUESTED BUT NONE HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED DEVICE MANUFACTURING DATE. ON (B)(6) 2017, MDR 3007966929-2017-00042- 895936, WAS SUBMITTED AND STATED THAT THE DATE OF THE URINE TEST WAS PROVIDED. THIS INFORMATION IS INCORRECT AS THE DATE OF TESTING IS UNKNOWN. NO SAMPLE WAS RECEIVED FOR THE COMPLAINT. A PICTURE WAS RECEIVED AND EVALUATED. THE PICTURE SHOWED THAT DEVICE WAS BROKEN. THE BROKEN DEVICE CANNOT BE USED. THE PICTURE IS NOT RELATED TO THE ISSUE. A BATCH RECORD REVIEW WAS PERFORMED. A NON-CONFORMANCE IS ASSOCIATED WITH THIS COMPLAINT, WHICH IS CLOSED. THE INVESTIGATION CONCLUDES THE LIKELY ROOT CAUSE FOR THE ISSUE ¿STOP FLOW BETWEEN PATIENT AND CHAMBER OF UDOMETER PRODUCT¿ CANNOT BE IDENTIFIED ON THE BASE OF INFORMATION RECEIVED. NO CORRECTIVE ACTION IS REQUIRED. NO ADDITIONAL INVESTIGATION IS NEEDED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    THE DISTRIBUTOR RECEIVED REPORTS FROM TWO HOSPITALS STATING ¿IT IS DIFFICULT TO DRAIN THE URINE FROM THE TUBING TO THE CHAMBER.¿ IT WAS REPORTED THAT THE URINE DID NOT FLOW FREELY IN THE TUBING WHEN THE UNOMETER SAFETY WAS CONNECTED TO THE CATHETER; HOWEVER, WHEN THE UNOMETER WAS NOT CONNECTED TO THE CATHETER, URINE FLOWED FREELY. THE REPORTER(S) WERE UNABLE TO PROVIDE ANY ADDITIONAL PATIENT(S) OR EVENT(S) DETAILS AS THEY STATED THIS INFORMATION IS CONFIDENTIAL. THEREFORE, IT IS UNKNOWN HOW MANY PATIENT(S) WERE INVOLVED PER THE QUANTITY OF DEVICE(S) REPORTED BY EACH HOSPITAL. IT WAS FURTHER REPORTED THAT A PATIENT REQUIRED A URINE TEST (RESULTS WERE NOT PROVIDED) AND THE UNOMETER SAFETI PLUS WAS REPLACED WITH ANOTHER UNOMETER. THE REPORTER WAS UNABLE TO PROVIDE SPECIFICS AS TO WHICH HOSPITAL THE FOLLOWING INFORMATION PERTAINS TO. THERE WAS NO PATIENT(S) HARMS REPORTED. NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED OR PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599012 URINE METER DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE FFG 158101310190 302598

    Patients

    Seq Age Sex Outcome Treatment
    1