BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIO

    MDR report key: 21571328 · Received March 11, 2025

    Report

    Report Number
    3003442380-2025-03210
    Event Type
    Injury
    Date Received
    March 11, 2025
    Date of Event
    February 8, 2025
    Report Date
    May 7, 2025
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    UDI-DI
    05705244020184
    PMA / PMN Number
    K160648
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: UNITED ARAB EMIRATES.

    Additional Manufacturer Narrative · 0

    CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED EXPIRATION DATE UNDER D4. 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- COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED FOR RECORD (B)(4) ON (B)(6) 2025. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6001412 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 31 ON (B)(6) 2023, 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 WAS IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED TRENDING: A QUERY WAS RUN IN DATABASE ON (B)(6) 2025 AGAINST HARM CODE NO MALFUNCTION BASED ON COMPLAINT INFORMATION, MALFUNCTION CODE NO MALFUNCTION DESCRIBE AND LOT 6001412 AND NO MORE COMPLAINT HAS BEEN REGISTERED IN DATABASE FOR THE SAME LOT, HARM CODE AND MALFUNCTION CODE. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION, ONLY ONE COMPLAINT RECEIVED ON THE LOT IN QUESTION AND HARM CODE, THE TEST ON REFERENCE SAMPLES WERE NOT TESTED SINCE A NO MALFUNCTION RELATED TO THE INFUSION SET WAS REPORTED, THEREFORE NO FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT WILL NOT REQUIRE FURTHER ROOT CAUSE INVESTIGATION NOR CORRECTIVE AND PREVENTIVE ACTION (CAPA) PLAN. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES. ROOT CAUSE OF PROBLEM: N/A - THIS COMPLAINT DID NOT REQUIRE ESCALATION TO CAPA; THEREFORE, NO FURTHER ROOT CAUSE INVESTIGATION HAS BEEN COMPLETED. CORRECTIVE ACTION AS A RESULT OF THE INVESTIGATION: N/A - THIS COMPLAINT DID NOT REQUIRE ESCALATION TO CAPA, THEREFORE NO CAPA PLAN IS AVAILABLE.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED ARAB EMIRATES. IT WAS REPORTED THAT THE PATIENT FACED AN EVENT ON 08-FEB-2025 WHERE THE PATIENT FACED HIGH BLOOD GLUCOSE LEVEL OF 580 MG/DL WHICH WAS TREATED BY MANUAL INJECTION. THE KETONES WERE MORE THAN 2 MMOL/L. MOREOVER, THE SYMPTOMS WERE VOMITING, DIZZINESS, STOMACH PAIN AND WAS UNRESPONSIVE. THEREFORE, THE PATIENT WAS HOSPITALIZED WITH BLOOD GLUCOSE LEVEL OF 380 MG/DL. THE PATIENT WAS HOSPITALIZED FOR LESS THAN TWENTY-FOUR HOURS. DURING HOSPITALIZATION, THE PATIENT WAS TREATED WITH MANUAL INJECTION AND CHANGING OF INFUSION SET. NO FURTHER INFORMATION 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
    1204565 MIO UNO INSET II 80/9 SC1 GREY MIMX FPA UNOMEDICAL UM-D MMT-975A 6001412 05705244020184

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention