BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILHOUETTE PARADIGM

    MDR report key: 20299011 · Received September 25, 2024

    Report

    Report Number
    3003442380-2024-24607
    Event Type
    Malfunction
    Date Received
    September 25, 2024
    Date of Event
    August 6, 2024
    Report Date
    February 21, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244019348
    PMA / PMN Number
    K162812
    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: CHINA.

    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 INFORMATION IN THIS COMPLAINT (B)(4) HAS BEEN EVALUATED. THE BATCH 6002575 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH WORK INSTRUCTION (WI) GUIDANCE FOR VISUAL TESTING FOR COMPLAINTS AREA VERSION 2 AND WI GUIDANCE FOR FUNCTIONAL TESTING FOR COMPLAINTS AREA VERSION 1 FOR THE CODE OCCLUSION IN THE TUBING AND/OR TUBING CONNECTORS (E.G., OCCLUSION ALARM FROM THE INFUSION PUMP MAY HAVE SOUNDED). COMPLAINT INVESTIGATIONS. PHOTO/SAMPLE WAS NOT PROVIDED. IN ORDER TO TEST THE PRODUCT, THE REFERENCE SAMPLES FROM THE LOT HAS BEEN REQUESTED. TEST RESULTS: VISUAL TEST ACCORDING TO WITH WI VERSION 2 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL TEST (FLOW TEST) 1 ACCORDING TO WI VERSION 1 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6002575 WAS MANUFACTURED ACCORDING TO THE WI VERSION 94 MANUFACTURED IN THE LINE/MACHINE M10, ON 31/AUG/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, NO MAINTENANCE EVENTS WERE RECORDED. DHR REVIEW ( GLUING TUBING): THE LOT 3G05149 WAS MANUFACTURED ACCORDING TO THE WI VERSION 55 MANUFACTURED IN THE LINE/MACHINE SC05-SC06, ON 17/AUG/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, NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 20/FEB/2025 AGAINST MALFUNCTION OCCLUSION IN THE TUBING AND/OR TUBING CONNECTORS (E.G., OCCLUSION ALARM FROM THE INFUSION PUMP MAY HAVE SOUNDED) AND LOT 6002575 AND NO ANOTHER COMPLAINTS HAVE BEEN REGISTERED IN TW FOR THE SAME LOT AND MALFUNCTION CODE. CONCLUSION SUMMARY OF THE RELATED EVENT. AS A RESULT OF THE FOLLOWING: NO DEFECT ON TESTS FOR REFERENCE SAMPLES, NO HARM REPORTED, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION, 1 OTHER COMPLAINT RECEIVED ON THE LOT IN QUESTION AND MALFUNCTION CODE, NO FURTHER ACTIONS ARE REQUIRED. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CHINA, IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT, WHO HAS TYPE 2 DIABETES WITH MULTIPLE COMPLICATIONS, WAS USING AN INSULIN PUMP FOR GLYCEMIC CONTROL AS PER DOCTOR'S ADVICE. ON (B)(6) 2024, THE INSULIN PUMP WAS REPORTED TO BE BLOCKED, LEADING TO HYPERGLYCEMIA (HIGH BLOOD GLUCOSE LEVELS) AND REQUIRING A CHANGE OF THE INFUSION SET. THE INFUSION SET WAS INSERTED ABOUT 5CM BESIDE THE BELLY BUTTON AND HAD BEEN IN USE FOR THREE DAYS. THE PATIENT EXPERIENCED A NO DELIVERY ALARM, WHICH WAS RESOLVED BY CHANGING THE INFUSION SET. THE PATIENT REQUIRED HOSPITALIZATION OR EMERGENCY MEDICAL TREATMENT, BUT THE EXACT BLOOD GLUCOSE VALUES WERE NOT PROVIDED. DUE TO THE TUBE BLOCKAGE CAUSING INCREASED BLOOD SUGAR, THE PATIENT'S HOSPITAL STAY WAS PROLONGED. 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
    2248691 SILHOUETTE PARADIGM UNO CONTACT DETACH G29 80/6 SC1 MIMX FPA UNOMEDICAL A/S MMT-866A 6002575 05705244019348

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown