BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YPSOPUMP INSET

    MDR report key: 22050522 · Received May 20, 2025

    Report

    Report Number
    3003442380-2025-09212
    Event Type
    Malfunction
    Date Received
    May 20, 2025
    Date of Event
    April 13, 2025
    Report Date
    May 6, 2025
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    PMA / PMN Number
    K032854
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION - THIS MDR IS BEING SUBMITTED TO INCLUDE THE BELOW: H6: INVESTIGATION RESULTS UNDER TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS H11: INVESTIGATION SUMMARY. THE INFORMATION IN THIS COMPLAINT (B)(4) HAS BEEN EVALUATED. THE BATCH 6010690 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH WORK INSTRUCTION (WI) GUIDANCE FOR VISUAL TESTING FOR COMPLAINTS AREA VERSION 3 AND WI GUIDANCE FOR FUNCTIONAL TESTING FOR COMPLAINTS AREA VERSION 2 FOR THE OCCLUSION (E.G., OCCLUSION ALARM FROM THE INFUSION PUMP MAY HAVE SOUNDED). (SOURCE/CAUSE CANNOT BE IDENTIFIED, ONLY USE WHEN A SPECIFIC MALFUNCTION CANNOT BE DETERMINED). IF THERE IS NO TROUBLESHOOTING, INCONCLUSIVE TROUBLESHOOTING, OR PARTIAL TROUBLESHOOT DONE AND IT CANNOT BE CONCLUDED TO BE INFUSION RELATED, REFER TO CANNOT BE DETERMINED CANNOT BE DETERMINED. NO ESCALATION REQUIRED. COMPLAINT INVESTIGATIONS. PHOTO/SAMPLE WAS NOT PROVIDED. IN ORDER TO TEST THE PRODUCT, THE REFERENCE SAMPLES FROM THE LOT HAVE BEEN REQUESTED. TEST RESULTS: VISUAL TEST ACCORDING TO WI VERSION 3 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL AIR FLOW TEST 1 ACCORDING TO WI VERSION 2 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6010690 WAS MANUFACTURED ACCORDING TO THE WI VERSION 75 MANUFACTURED IN THE LINE 5, ON 09/DEC/2024, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DHR SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESSES HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DEVIATION WERE IDENTIFIED; NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 06/MAY/2025 AGAINST MALFUNCTION CODE OCCLUSION (E.G., OCCLUSION ALARM FROM THE INFUSION PUMP MAY HAVE SOUNDED). (SOURCE/CAUSE CANNOT BE IDENTIFIED, ONLY USE WHEN A SPECIFIC MALFUNCTION CANNOT BE DETERMINED) AND LOT 6010690 AND NO MORE COMPLAINT HAVE BEEN REGISTERED IN DATABASE FOR THE SAME LOT AND MALFUNCTION CODE. CONCLUSION SUMMARY OF THE RELATED EVENT: AS A RESULT OF THE FOLLOWING: NO DEFECT ON TESTS FOR RETENTION SAMPLES, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION. NO FURTHER ACTIONS ARE REQUIRED. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN GERMANY. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INSULIN FLOW BLOCKED AND HIGH BLOOD GLUCOSE LEVELS ON (B)(6) 2025. IT WAS ALSO REPORTED THAT THE PATIENT WENT TO THE EMERGENCY ROOM (ER) AND WAS ADMITTED TO HOSPITAL FROM (B)(6) 2025 AND RECEIVED INTRAVENOUS (IV) FLUIDS WITH INSULIN SALINE AND THE PATIENT BLOOD GLUCOSE LEVELS WHILE ADMITTING THE HOSPITAL WAS 500 MG/DL. THE PATIENT EXPERIENCED KETONES WHICH WERE 3.8 MMOL/DL. NO FURTHER INFORMATION WAS AVAILABLE.

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2142519 YPSOPUMP INSET UNO INSET II 60/6 GREY Y-CAP 10PAK INT FPA UNOMEDICAL UM-D 86-060-52B6 6010690

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention