BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINMED QUICK SET

    MDR report key: 19936563 · Received August 8, 2024

    Report

    Report Number
    3003442380-2024-19419
    Event Type
    Malfunction
    Date Received
    August 8, 2024
    Date of Event
    June 27, 2024
    Report Date
    October 23, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018051
    PMA / PMN Number
    K160648
    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 INVESTIGATION ASSOCIATED WITH RELATED EVENT (B)(4) 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 SURVELLIENCE (PMS) PRODUCT TRENDS AND MALFUNCTION ACCORDING TO THE MARKET QUALITY REVIEW (MQR) PROCEDURE. THE IDENTIFIED MALFUNCTION CODE, SOFT CANNULA FOUND BENT UPON REMOVAL FROM INFUSION SITE, IS NOT ASSOCIATED WITH A DESIGN OR MANUFACTURING-RELATED COMPLAINT ISSUE. THEREFORE, A DETAILED INVESTIGATION OR INSPECTION OF REFERENCE SAMPLES IS NOT REQUIRED. BATCH REVIEW: LOT 6001323 WAS MANUFACTURED ON 19-MAY-2023, IN MACHINE 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. DURING MANUFACTURING OF THE CANNULA PART, THE SOFT CANNULA IS KEPT STRAIGHT BY THE INTRODUCER NEEDLE, NO SAMPLES WERE RETURNED FOR INSPECTION. HOWEVER, DURING USE IN GENERAL AND SPECIFICALLY DURING INSERTION MAY ACCIDENTALLY KINK THE SOFT CANNULA. NO FURTHER ACTION IS REQUIRED FOR THIS COMPLAINT, IF USED/UNUSED SAMPLES ARE RECEIVED, APPROPRIATE ACTIONS WILL BE TAKEN.

    Additional Manufacturer Narrative · 0

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

    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 BAHRAIN. IT WAS REPORTED THAT PATIENT FACED INFUSION SET BENT CANNULA EVENT AND EVENTUALLY GOT HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS ON (B)(6) 2024 . THE DURATION OF HOSPITALIZATION WAS 4 HOURS. THE GLUCOSE LEVEL WAS 24MMOL/L AND THE PATIENT WAS TREATED WITH IV INSULIN DRIP. COMPANY 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 AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2396101 MINMED QUICK SET UNO QUICK-SET 110/9 SC1 MECA FPA UNOMEDICAL A/S MMT-396A 6001323 05705244018051

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization