BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK SET PARADIGM

    MDR report key: 19728508 · Received July 12, 2024

    Report

    Report Number
    3003442380-2024-13711
    Event Type
    Injury
    Date Received
    July 12, 2024
    Date of Event
    May 26, 2024
    Report Date
    August 30, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244017931
    PMA / PMN Number
    K160648
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E1: PATIENT CITY: (B)(6)PATIENT COUNTRY: (B)(6)

    Additional Manufacturer Narrative · 0

    CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED EXPIRATION DATE UNDER D4 AND MANUFACTURING DATE UNDER H4. 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 FOR THE MALFUNCTION CODE MALFUNCTION CANNOT BE DETERMINED. THE BATCH 6002385 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. COMPLAINT INVESTIGATION: THE REFERENCE SAMPLES CANNOT BE TESTED BECAUSE THERE WAS NO SPECIFIC MALFUNCTION TO INVESTIGATE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6002385 WAS MANUFACTURED ACCORDING TO THE DOCUMENT WORK INSTRUCTION (WI) VERSION 77 ON THE PACKING PROCESS IN THE MACHINE MUTLTIVAC 12, ON 19/JUL/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 WERE IDENTIFIED RELATED TO THE MALFUNCTION REPORTED, NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 11/AUG/2025 AGAINST MALFUNCTION CODE MALFUNCTION CANNOT BE DETERMINED, HARM CODE SIGNS OF UNTREATED HYPOGLYCAEMIA THAT PATIENT IS UNABLE TO SELF-MANAGE REQUIRING INTERVENTION BY AN HEALTH CARE PROVIDER (HCP) OR REQUIRES EMERGENCY ADVANCED LIFE SUPPORT TO PREVENT PERMANENT ORGAN DAMAGE AND LOT 6002385 AND NO OTHER COMPLAINTS HAVE BEEN REGISTERED IN DATABASE FOR THE SAME LOT NUMBER, HARM CODE AND MALFUNCTION CODE. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, NO OTHER COMPLAINT RECEIVED ON THE LOT IN QUESTION, HARM CODE AND MALFUNCTION CODE, NO FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT WILL NOT REQUIRE FURTHER ROOT CAUSE INVESTIGATION OR CORRECTIVE AND PREVENTIVE ACTION (CAPA) PLAN. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES IT WAS REPORTED THAT THE PATIENT VISITED ER AND EVENTUALLY HOSPITALISED DUE TO HIGH BLOOD GLUCOSE FROM (B)(6)2024 TO 04-JUN-2024. THE GLUCOSE LEVEL WAS 161 MG/DL AND THE PATIENT WAS TREATED WITH LONG ACTIVE INSULIN 35U A DAY IN THE MORNING AND 10U DURING MEALS OF MANUAL INJECTION. 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
    2349002 QUICK SET PARADIGM UNO QUICK-SET 110/6 SC1 MECA FPA UNOMEDICAL A/S MMT-398A 6002385 05705244017931

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| S