BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3841778 · Received May 30, 2014

    Report

    Report Number
    2032227-2014-02706
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    February 28, 2013
    Report Date
    May 12, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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 CALLED TO REPORT HOSPITALIZATION FOR INFECTION AT THE INSERTION SITE, HIGH BLOOD GLUCOSE LEVELS AND A CYST THAT HAD FORMED. CUSTOMER STATED THAT A BOLUS WAS NOT DELIVERED. CUSTOMER'S BLOOD GLUCOSE LEVEL HAD INCREASED TO 600 MG/DL AT TIME OF HOSPITALIZATION. DURING TROUBLESHOOTING, IT WAS FOUND THAT THE BATTERY CAP HAD BEEN DAMAGED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319554 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Hospitalization