BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 4466882 · Received January 29, 2015

    Report

    Report Number
    3004209178-2015-89096
    Event Type
    Injury
    Date Received
    January 29, 2015
    Date of Event
    January 13, 2015
    Report Date
    January 15, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE MEDWATCH 2032227-2014-17654 FOR ADDITIONAL INFORMATION. CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED ON (B)(6) 2015 DUE TO A HIGH BLOOD GLUCOSE LEVEL OF 469 MG/DL. THE CUSTOMER WAS EXPERIENCING NUMBNESS IN HIS HANDS AND PAIN IN HIS CHEST. HE WAS ADMINISTERED INSULIN SHOTS. THE CUSTOMER WAS WEARING HIS INSULIN PUMP AT THE TIME OF HOSPITALIZATION. THE PRODUCT WAS NOT RETURNED. NOTHING FURTHER TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68715 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-715NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization