BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILHOUETTE PARADIGM INFUSION SET

    MDR report key: 7124939 · Received December 18, 2017

    Report

    Report Number
    8021545-2017-00008
    Event Type
    Injury
    Date Received
    December 18, 2017
    Date of Event
    August 16, 2017
    Report Date
    December 18, 2017
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244008588
    PMA / PMN Number
    K162812
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW, LEAK AND VENTILATION TO THE PCC RESERVOIR CONNECTOR. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. THE CLAIMED FAILURE CANNOT BE CONFIRMED. AN INVESTIGATION HAS BEEN PERFORMED BASED ON THE CUSTOMER COMPLAINT DESCRIPTION AND THE REFERENCE SAMPLES FROM THE SAME LOT NUMBER. ACCORDING TO UNOMEDICAL'S TRACEABILITY RECORDS, NO RELEVANT DEVIATIONS WERE FOUND. IF NEW INFORMATION BECOMES AVAILABLE, THE COMPLAINT WILL BE RE-OPENED AND APPROPRIATE ACTIONS WILL BE TAKEN.

    Description of Event or Problem · 1

    (B)(4). FDA REPORT NUMBER: MW5072202. ON (B)(6) 2017 A DIABETIC PATIENT ON PUMP THERAPY FELL INTO DIABETIC COMA AND REQUIRED THE EMERGENCY SERVICES OF THE PARAMEDICS WHEN THE PATIENTS PARTNER HEARD THE PATIENT BREATHING STRANGELY AND WAS NOT ABLE TO AROUSE THE PATIENT. THE PARAMEDICS CHECKED THE BLOOD GLUCOSE AND IT WAS SO LOW THEY WERE NOT ABLE TO GET A READING. THE PARAMEDICS WERE ABLE TO TREAT THE PATIENT AND EVENTUALLY REVIVE THE PATIENT AFTER AN HOUR. THE PATIENT RECENTLY FOUND OUT OF MEDTRONICS RECALL OF THE MMT-381 INFUSION SET LOT NUMBER 5150522 WHICH THE PATIENT HAD BEEN USING AT THE TIME OF THE INCIDENT. IT LEADS THE PATIENT TO BELIEVE THAT THE HYPOGLYCEMIC COMA INCIDENT WAS DUE TO THE FAILURE OF THE INFUSION SET SINCE THERE WAS NO OTHER EXPLANATION AS TO WHY THE PATIENT'S BLOOD GLUCOSE WOULD HAVE BEEN DROPPED SO LOW. THE INCIDENT WAS VERY UNSETTLING AND CAUSED THE PATIENT A GREAT DEAL OF EMOTIONAL DISTRESS AND MORE. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    903679 SILHOUETTE PARADIGM INFUSION SET SILHOUETTE PARADIGM FPA UNOMEDICAL A/S MMT-381 5150522 05705244008588

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening