BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3864645 · Received June 10, 2014

    Report

    Report Number
    2032227-2014-03044
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 23, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    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 THAT SHE HAD UNEXPLAINED HIGH BLOOD GLUCOSE. CUSTOMER STATED THAT SHE WAS TAKEN TO THE EMERGENCY ROOM AND WAS HOSPITALIZED. THE BLOOD GLUCOSE READING WAS 599 MG/DL. CUSTOMER STATED THAT SHE WAS HAVING A HEADACHE AND ABDOMINAL PAIN. CUSTOMER ALSO STATED THAT HER INFUSION SET CANNULA WAS BENT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341332 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523RNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization UNOMEDICAL INSULIN INFUSION SET