BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4143028 · Received September 27, 2014

    Report

    Report Number
    2032227-2014-30077
    Event Type
    Injury
    Date Received
    September 27, 2014
    Date of Event
    August 1, 2013
    Report Date
    August 29, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OF 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 OUT KNOWLEDGE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER'S WIFE THAT THE CUSTOMER WAS HOSPITALIZED 3 TIMES FOR DIABETES RELATED ISSUES. FIRST ADMISSION (B)(6) 2013. SECOND TIME (B)(6) 2014 CUSTOMER'S BLOOD GLUCOSE LEVEL AT THE TIME 28 MG/DL. CUSTOMER WAS TREATED WITH GLUCAGON SHOT. THIRST HOSPITALIZATION WAS ON (B)(4) 2014. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603517 PARADIGM REAL TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R