BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523LNAS

    MDR report key: 3924223 · Received July 9, 2014

    Report

    Report Number
    2032227-2014-03525
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 20, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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

    CUSTOMER REPORTED HOSPITALIZATION DUE TO HIGH BLOOD GLUCOSE. CUSTOMER STATED THAT THE CANNULAS ARE BENDING. THE SERTER COULD BE THE PROBLEM. THE BLOOD GLUCOSE READING AT THE TIME OF THE EVENT WAS 441 MG/DL. CUSTOMER EXPERIENCING MUSCLE ACHE, NAUSEA AND NECK PAIN. CUSTOMER TREATED WITH MANUAL INJECTION. CUSTOMER REQUESTED A QUICKSERTER. THE CURRENT BLOOD GLUCOSE READING IS 569 MG/DL. CUSTOMER TREATED WITH MANUAL INJECTION. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400493 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523LNAS INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization