BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2991793 · Received March 6, 2013

    Report

    Report Number
    2032227-2013-00901
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    February 10, 2013
    Report Date
    February 10, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE
    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

    THE CUSTOMER STATED THAT SHE WAS HOSPITALIZED DUE TO BLOOD GLUCOSE LEVELS GREATER THAN 800 MG/DL. THE CUSTOMER DID NOT FEEL THAT THE EVENT WAS INSULIN PUMP RELATED. THE CUSTOMER COULD NOT RECALL WHETHER OR NOT THE INFUSION SET WAS CONNECTED TO HER BODY WHEN SHE WAS FOUND. THE CUSTOMER DECLINED TO TROUBLESHOOT AS SHE DID NOT FEEL THAT THE INSULIN PUMP HAD ANYTHING TO DO WITH THE EVENT. THE CUSTOMER FELT THAT SHE NEEDED TO SWITCH TO A DIFFERENT INFUSION SET. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96015 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523RNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization