BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 23241781 · Received October 8, 2025

    Report

    Report Number
    3003442380-2025-14759
    Event Type
    Injury
    Date Received
    October 8, 2025
    Date of Event
    November 9, 2025
    Report Date
    January 17, 2026
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: UNITED STATES. H11: SINCE NO LOT NUMBER IS AVAILABLE, A DETAILED INVESTIGATION, TESTS ON REFERENCE SAMPLES OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE, THIS COMPLAINT WILL BE CLOSED, THIS ISSUE WILL BE MONITORED THROUGH POST MARKETING SURVEILLANCE (PMS) PRODUCT TRENDS AND MALFUNCTION. IF ANY TRENDS PICKED UP, THIS WILL FLAG ON THE TRIPS AND ALERTS ACCORDING TO THE ON MARKET QUALITY REVIEW (OMQR) PROCEDURE.

    Additional Manufacturer Narrative · 0

    UNOMEDICAL HEREBY SUBMITS THIS SUPPLEMENTAL REPORT AS PART OF ITS COMPLAINT REMEDIATION ACTIVITIES CONDUCTED UNDER A CAPA/FDA ACTION PLAN.THIS SUBMISSION INCLUDES A RETROSPECTIVE REASSESSMENT OF PREVIOUSLY EVALUATED COMPLAINTS. UNOMEDICAL IS PROVIDING THIS SUPPLEMENTAL INFORMATION IN ACCORDANCE WITH THE REPORTING REQUIREMENTS SET FORTH IN 21 CFR PART 803. ANY FIELDS LEFT BLANK INDICATE THAT THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR REMAINS UNCHANGED. MDR RETRACTION: THE INITIAL MDR WITH MANUFACTURING REPORT NUMBER (3003442380-2025-14759), WAS SUBMITTED ON 08 OCT 2025. HOWEVER, BASED ON THE INVESTIGATION RESULTS DONE ON 17-JAN-2026 AND CLINICAL REVIEW DONE ON 23-JAN-2026, IT WAS FOUND THAT THE SERIOUS INJURY WAS NOT RELATED TO INFUSION SET AND THERE IS NO ALLEGATION ON THE INFUSION SET. NOW, THIS CASE HAS BEEN DETERMINED TO BE NON-REPORTABLE. HENCE, THIS MDR IS BEING SUBMITTED TO RETRACT THE INITIAL MDR. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT GOT HOSPITALIZED ON (B)(6) 2025 DUE TO DIABETIC KETOACIDOSIS. THE BLOOD GLUCOSE LEVEL 600 MG/DL AND ALSO HAVE EXTREMITY PAIN/CRAMPS. THE PATIENT GOT TREATED WITH MANUA BOLUS AND INTRAVENOUS (IV). 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
    412013 UNKNOWN UNKNOWN FPA UNOMEDICAL UM-D UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1