BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC QUICK-SET PARADIGM INFUSION SET

    MDR report key: 9478955 · Received December 17, 2019

    Report

    Report Number
    3003442380-2019-00008
    Event Type
    Death
    Date Received
    December 17, 2019
    Date of Event
    November 18, 2019
    Report Date
    December 16, 2019
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244006416
    PMA / PMN Number
    K106648
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT 5154294. REFERENCE SAMPLES HAVE BEEN ANALYSED WITHOUT ANY FINDINGS OF MALFUNCTIONS. A BATCH REVIEW HAS BEEN CONDUCTED: ALL WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    UNOMEDICAL REFERENCE (B)(4) (MEDTRONIC REF SVN (B)(4)). ON 25-NOV-2019 MEDTRONIC INFORMS UNOMEDICAL ABOUT A LEGAL, FATAL CASE. A (B)(6) YEAR OLD FEMALE DIABETIC PATIENT IS TREATED WITH INSULIN VIA A MEDTRONIC INSULIN PUMP AND A QUICK-SET INSULIN INFUSION SET, MODEL MMT-397, MANUFACTURED BY UNOMEDICAL. A LAWYER ALLEGES THAT SHE DIED ON (B)(6) 2019 FOLLOWING AN OVERDOSE OF INSULIN CAUSED BY INFUSION SET VENT BLOCK MEMBRANE FAILURE. THE OVERDOSE ALLEGEDLY LED TO SEVERE HYPOGLYCEMIA WHICH WAS NOT TREATED AND THUS ULTIMATELY LED TO THE DEATH OF THE PATIENT. NOTE: THE FATAL INCIDENT OCCURRED SOME 2 MONTHS AFTER MEDTRONIC AND UNOMEDICAL LAUNCHED A VOLUNTARY RECALL OF THE POTENTIALLY AFFECTED INFUSION SET PRODUCTS ON 11-SEP-2017. RECALL REFERENCES ARE UNOMEDICAL: MA-2017-02; MEDTRONIC: FA-784. AT THE MOMENT WE DO NOT HAVE FURTHER FACTS ON THE FATAL INCIDENT. DUE TO THE SCARCE INFORMATION AVAILABLE UNOMEDICAL CANNOT PRESENTLY MAKE ANY REASONABLE ASSESSMENT OF POSSIBLE CAUSAL RELATION BETWEEN THE FATAL INCIDENT AND THE USED INFUSION SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1277533 MEDTRONIC QUICK-SET PARADIGM INFUSION SET INSULIN INFUSION SET FPA UNOMEDICAL A/S MMT-397 5154294 05705244006416

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death