BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINMED QUICK SET

    MDR report key: 21176876 · Received January 17, 2025

    Report

    Report Number
    3003442380-2024-37393
    Event Type
    Injury
    Date Received
    January 17, 2025
    Date of Event
    December 23, 2024
    Report Date
    August 18, 2025
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    UDI-DI
    05705244017450
    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

    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. THE INFORMATION IN THIS COMPLAINT (B)(4) HAS BEEN EVALUATED FOR THE MALFUNCTION CODE SOFT CANNULA FOUND BENT UPON REMOVAL FROM INFUSION SITE. THE BATCH 6003014 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. COMPLAINT INVESTIGATIONS. PHYSICAL SAMPLES WERE FORMALLY REQUESTED; HOWEVER, THEY WERE NOT PROVIDED. IN ORDER TO TEST THE PRODUCT, THE REFERENCE SAMPLES FROM THE LOT HAVE BEEN REQUESTED. HOWEVER, THE REFERENCE SAMPLES FOR BATCH 6003014 WERE PREVIOUSLY TESTED IN COMPLAINT (B)(4) ON 01/JUL/2024. TEST RESULTS: THE FOLLOWING TESTS WERE COMPLETED FOR 10 REFERENCE SAMPLES OF LOT 6003014: 1. VISUAL INSPECTION AS PER 4902117. ALERTA DE CALIDAD (CATHETER DOBLADO) / QUALITY ALERT (KINKED CANNULA) NO DAMAGE O BENT WERE FOUND. 2. 4802011, FLOW TEST ON CUSTOMER COMPLAINTS -PRUEBAS DE FLUJO EN QUEJAS DEL CLIENTE, VERSION 10. 10 REFERENCE SAMPLES MET THE CRITERIA OF MINIMUM 80ML/MINUTE. FLOW TEST VALUES OF REFERENCE SAMPLES: P1: 133, P2: 125, P3: 131, P4: 147, P5; 128, P6: 127, P7: 129, P8: 127, P9: 91, P10: 122. DEVICE HISTORY RECORD (DHR) REVIEW: PACKING OF QUICK SET. LOT 6003014 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 77 AND PACKAGING IN THE MULTIVAC 12, ON 06/SEP/2023, WITH A TOTAL OF (B)(4) UNITS. ASSEMBLY OF QUICK SET: LOT 3H04063 WAS MANUFACTURED ACCORDING TO THE WI VERSION 26 ASSEMBLED IN THE QUICKSET LINE, ON 06/SEP/2023, WITH A TOTAL OF (B)(4) UNITS. LOT 3H04062 WAS MANUFACTURED ACCORDING TO THE WI VERSION 26 ASSEMBLED IN THE QUICKSET LINE, ON 06/SEP/2023, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DEVICE HISTORY RECORD (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 18/AUG/2025 AGAINST MALFUNCTION CODE SOFT CANNULA FOUND BENT UPON REMOVAL FROM INFUSION SITE AND LOT 6003014 AND OTHER 11 COMPLAINTS HAVE BEEN REGISTERED IN DATABASE FOR THE SAME LOT 6003014 AND MALFUNCTION CODE. PRELIMINARY CONCLUSION: DUE TO THE VOLUME OF COMPLAINTS IDENTIFIED IN THE TRENDING ANALYSIS, THIS CASE WILL BE MOVED TO PENDING CORRECTIVE AND PREVENTIVE ACTION (CAPA) DETERMINATION ASSESSMENT TO EVALUATE WHETHER ADDITIONAL INVESTIGATION IS REQUIRED.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN UNITED ARAB EMIRATES. IT WAS REPORTED THAT THE PATIENT FACED ABENT CANNULA EVENT ON (B)(6) 2024. THE PATIENT TRIED TO TREAT IT WITH MANUAL INJECTION. THEREFORE, THE PATIENT WAS HOSPITALISED DUE TO HIGH BLOOD GLUCOSE LEVEL OF 487 MG/DL. ALSO, THE PATIENT HAD HIGH KETONES OF 8 MMOL/L, WAS SICK AND UNWELL. THE PATIENT WAS HOSPITALISED LESS THAN 24 HOURS. DURING HOSPITALISATION, THE PATIENT WAS TREATED WITH MANUAL INJECTION. 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 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
    1111391 MINMED QUICK SET UNO QUICK-SET 60/6 SC1 MECA FPA UNOMEDICAL UM-D MMT-399A 6003014 05705244017450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention