BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILHOUETTE

    MDR report key: 21716506 · Received March 28, 2025

    Report

    Report Number
    3003442380-2025-04781
    Event Type
    Malfunction
    Date Received
    March 28, 2025
    Date of Event
    February 27, 2025
    Report Date
    September 23, 2025
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    UDI-DI
    05705244019584
    PMA / PMN Number
    K162812
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    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: REVISION 21 OF (B)(4) DOES NOT REQUIRE A COMPLAINT THAT IS TYPE 2 REPORTABLE TO OPEN A CHILD INVESTIGATION. THIS CHILD INVESTIGATION WAS OPENED AGAINST A PREVIOUS REVISION OF (B)(4). COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6007690, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. THRESHOLD ANALYSIS: A QUERY WAS RUN ON 22-SEP-2025 AGAINST "FINAL REPORTING DECISION EQUAL "SERIOUS INJURY" AND "DEATH", "LOT NUMBER" CRITERIA EQUAL "6007690". THE COUNT OF COMPLAINT IS 0 WHICH IS BELOW 3. NO FURTHER STATISTICAL TRENDING ANALYSIS IS REQUIRED. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6007690WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 18 AND MANUFACTURED IN THE MACHINE MULTIVAC 14 ON 20/SEP/2024, WITH A TOTAL OF (B)(4) UNITS. GLUE-TUBING LOT: THE LOT 4F01638 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 15 AND MANUFACTURED IN THE MACHINE LC01 ON 11/JUN/2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4F02573 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 15 AND MANUFACTURED IN THE MACHINE LC01 ON 16/JUN/2024, WITH A TOTAL OF (B)(4)UNITS. REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWED THAT A NON-CONFORMANCE (NC) 191882 WAS OPENED DURING THE STERILIZATION PROCESSES ACTIONS WERE REQUIRED. THEREFORE, DEVICE HISTORY RECORD (DHR) SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESSES HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DEVIATION WAS IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED RELATED TO COMPLAINT CODE. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: ONE NON-CONFORMANCE (NC) RAISED DURING STERILIZATION PROCESS UNRELATED TO COMPLAINT CODE, THEREFORE, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, NO FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT WILL NOT REQUIRE FURTHER ROOT CAUSE INVESTIGATION NOR CORRECTIVE AND PREVENTIVE ACTION (CAPA) PLAN. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURED IN THE UNITED STATES. ON (B)(6) 2025, THE PATIENT EXPERIENCED INSULIN FLOW BLOCK ALARM EVENT WITH THEIR INFUSION SETS. THE BLOCKAGE WAS AT TUBING. 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
    1603544 SILHOUETTE UNO COMFORT SHORT 60/13 SC1 MIN FPA UNOMEDICAL UM-D MMT-381A 6007690 05705244019584

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown