BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED QUICK-SET

    MDR report key: 21705631 · Received March 27, 2025

    Report

    Report Number
    3003442380-2025-04598
    Event Type
    Injury
    Date Received
    March 27, 2025
    Date of Event
    February 17, 2025
    Report Date
    June 27, 2025
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    UDI-DI
    05705244017573
    PMA / PMN Number
    K160648
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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. THE BATCH 6010032 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. THE REFERENCE SAMPLES FOR THE LOT 6010032 HAVE ALREADY BEEN PREVIOUSLY TESTED FOR VISUAL INSPECTION AND TESTED FOR FLOW IN THE COMPLAINT (B)(4) ON 08/JUN/2025. ALL TEST RESULTS WERE FOUND WITHIN SPECIFICATIONS AS PER THE TEST REPORT COMPLAINT 2155376 TEST REPORT.PDF ATTACHED IN THIS RECORD. COMPLAINT INVESTIGATIONS. PHOTO/SAMPLE WAS NOT PROVIDED. IN ORDER TO TEST THE PRODUCT, THE REFERENCE SAMPLES FROM THE LOT HAVE BEEN REQUESTED. TEST RESULTS: VISUAL TEST ACCORDING TO WORK INSTRUCTION (WI) VERSION 3.0 ON REFERENCE SAMPLES, 10/10 SAMPLES PASSED THE TEST. FUNCTIONAL AIR FLOW TEST ACCORDING TO WI VERSION 2.0 ON REFERENCE SAMPLES, 10/10 SAMPLES PASSED THE TEST. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6010032 WAS MANUFACTURED ACCORDING TO THE WI VERSION 82 AND PACKAGING IN THE MULTIVAC 12, ON 29/OCT/2024, WITH A TOTAL OF (B)(4) UNITS. ASSEMBLY LOT: THE LOT 4K05682 WAS MANUFACTURED ACCORDING TO THE WI VERSION 27 ASSEMBLED IN THE QUICKSET LINE, ON 28/OCT/2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4K05683 WAS MANUFACTURED ACCORDING TO THE WI VERSION 27 ASSEMBLED IN THE QUICKSET LINE, ON 28/OCT/2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4K06592 WAS MANUFACTURED ACCORDING TO THE WI VERSION 27 ASSEMBLED IN THE QUICKSET LINE, ON 30/OCT/2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4K05698 WAS MANUFACTURED ACCORDING TO THE WI VERSION 27 ASSEMBLED IN THE QUICKSET LINE, ON 02/NOV/2024, WITH A TOTAL OF (B)(4) UNITS. GLUE-TUBING LOT: THE LOT 4K05238 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 IN THE GLUING OF QUICK SET MACHINE MP04, MP08, ON 26/OCT/2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4K05680 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 IN THE GLUING OF QUICK SET MACHINE MP04, MP05, MP08, ON 30/OCT/2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4K05113 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 IN THE GLUING OF QUICK SET MACHINE MP04, MP08, ON 25/OCT/2024, WITH A TOTAL OF (B)(4) UNITS. WELDING LOT: THE LOT 4K05092 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 IN THE MACHINE SC05, SC06, ON 28/OCT/2024, 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 26/JUN/2025 AGAINST MALFUNCTION CODE OCCLUSION (E.G., OCCLUSION ALARM FROM THE INFUSION PUMP MAY HAVE SOUNDED). (SOURCE/CAUSE CANNOT BE IDENTIFIED, ONLY USE WHEN A SPECIFIC MALFUNCTION CANNOT BE DETERMINED). IF THERE IS NO TROUBLESHOOTING, INCONCLUSIVE TROUBLESHOOTING, OR PARTIAL TROUBLESHOOT DONE AND IT CANNOT BE CONCLUDED TO BE INFUSION RELATED, REFER TO CANNOT BE DETERMINED CANNOT BE DETERMINED. NO ESCALATION REQUIRED AND LOT 6010032 AND NO OTHER COMPLAINTS HAVE BEEN REGISTERED IN DATABASE FOR THE SAME LOT AND MALFUNCTION CODE. CONCLUSION SUMMARY OF THE RELATED EVENT: AS A RESULT OF THE FOLLOWING: ON THE INVESTIGATION ON REFERENCE SAMPLES, NO ISSUE WERE FOUND RELATED TO OCCLUSION, HARM NO REPORTABLE, NO DEFECT ON TESTS, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION, NO MORE COMPLAINT WAS RECEIVED ON THE LOT IN QUESTION AND MALFUNCTION, NO FURTHER ACTION ARE REQUIRED, THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES.

    Additional Manufacturer Narrative · 0

    E1: PATIENT CITY: (B)(6), PATIENT COUNTRY: 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 OCCURED IN THE UNITED STATES. THE PATIENT REPORTEDLY VISITED THE EMERGENCY ROOM DUE TO INSULIN FLOW BLOCK ALARM EVENT ON 17-FEB-2025, AND WAS ADMITTED TO THE HOSPITAL ON THE SAME DAY. THE HOSPITAL STAY LASTED UNTIL FEBRUARY (B)(6) 2025, WHICH WAS MORE THAN 24 HOURS. UPON ADMISSION, THE PATIENT'S BLOOD GLUCOSE LEVEL WAS ALARMINGLY HIGH AT 1117 MG/DL. THE PRIMARY REASON FOR HOSPITALIZATION WAS THE SEVERELY ELEVATED BLOOD SUGAR. AT THE TIME OF ADMISSION, THE PATIENT REPORTED EXPERIENCING FLU-LIKE SYMPTOMS AND VOMITING. DURING THE HOSPITAL STAY, INSULIN WAS ADMINISTERED THROUGH INTRAVENOUS DRIPS. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1437414 MINIMED QUICK-SET UNO QUICK-SET 60/9 SC1 MECA FPA UNOMEDICAL UM-D MMT-397A 6010032 05705244017573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R