BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINMED QUICK SET

    MDR report key: 19901892 · Received August 3, 2024

    Report

    Report Number
    3003442380-2024-18835
    Event Type
    Malfunction
    Date Received
    August 3, 2024
    Date of Event
    July 3, 2024
    Report Date
    September 4, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018051
    PMA / PMN Number
    K160648
    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 INVESTIGATION ASSOCIATED WITH RELATED EVENT DATABASE 1930209 HAS BEEN APPROVED AND IS COMPLETE. NO ADDITIONAL ACTION IS REQUIRED, AND THIS COMPLAINT WILL BE CLOSED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKETING SURVEILLANCE (PMS) PRODUCT TRENDS AND MALFUNCTION ACCORDING TO THE MARKET QUALITY REVIEW (OMQR) PROCEDURE. THE IDENTIFIED FOR MALFUNCTION CODE, IS NOT ASSOCIATED WITH A DESIGN OR MANUFACTURING-RELATED COMPLAINT ISSUE. THEREFORE, A DETAILED INVESTIGATION OR INSPECTION OF REFERENCE SAMPLES IS NOT REQUIRED. LOT 6004813 WAS MANUFACTURED ON 07-JAN-2024, IN 12, WITH A TOTAL OF (B)(4). THE BATCH RECORD WAS REVIEWED TO VERIFY IF ALL THE APPLICABLE PROCEDURES WERE FOLLOWED, AND NO ISSUES WERE FOUND. REVIEW OF THE BATCH RECORD SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE MANUFACTURING PROCESS AND FINAL PRODUCT RELEASE HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DISCREPANCY RELATED TO THIS ISSUE WAS FOUND WITHIN THE DOCUMENTATION. CONCLUSION SUMMARY OF THE RELATED EVENT. DUE TO THE FOLLOWING BATCH RECORD REVIEW YIELDING NO DISCREPANCIES AND NO NON-CONFORMANCE (NC) WAS GENERATED DURING PRODUCTION. SOFT CANNULA CRIMPING COULD OCCUR DURING SEVERAL STEPS OF MANUFACTURING AND WHEN THE TIP OF THE SOFT CANNULA IS DAMAGED, NO SAMPLES WERE RETURNED FOR INSPECTION. HOWEVER, DURING USE, SOFT CANNULA CRIMPING CAN BE CAUSED BY USING INCORRECT INSERTION TECHNIQUES OR CHOOSING AN INAPPROPRIATE INSERTION SITE OR CANNULA LENGTH. NO FURTHER ACTION IS REQUIRED FOR THIS COMPLAINT, IF NEW INFORMATION BECOMES AVAILABLE OR USED/UNUSED SAMPLES ARE RECEIVED, APPROPRIATE ACTIONS WILL BE TAKEN.

    Additional Manufacturer Narrative · 0

    E1: PATIENT CITY: (B)(6) PATIENT COUNTRY : THE UNITED STATES

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4) EVENT OCCURRED IN THE UNITED STATES. ON (B)(6)2024, IT WAS REPORTED THAT THE PATIENT ENCOUNTERED INFUSION SET CANNULA KINKED EVENT. INFUSION SET WAS IN USE FOR 2 DAYS. THE BLOOD GLUCOSE LEVEL WAS REPORTED 250 MMOL/L. DO NOT SEE BENT/KINKING AS BEING RELATED TO HUMAN FACTORS, BUT RATHER AS A TRAINING ISSUE INCLUDING CORRECT CHOICES OF INSERTION SITES AND INFUSION SETS AND CANNULA LENGTH. FURTHERMORE, THE SOFT CANNULA IS A FLEXIBLE MATERIAL THAT DURING USE AND UPON REMOVAL CAN BEND SLIGHTLY. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    951592 MINMED QUICK SET UNO QUICK-SET 110/9 SC1 MECA FPA UNOMEDICAL A/S MMT-396A 6004813 05705244018051

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown