BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3022021 · Received March 26, 2013

    Report

    Report Number
    2032227-2013-01161
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    March 9, 2013
    Report Date
    March 11, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    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. PLEASE SEE ALSO MFR. REPORT NUMBER 2032227-2013-01162.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HE WAS HOSPITALIZED WITH A LOW BLOOD GLUCOSE OF 26 MG/DL. THE CUSTOMER STATED THAT HE USUALLY EATS A SNACK TWO HOURS AFTER MEALS, BUT MISSED HIS SNACK THIS TIME. THE CUSTOMER STATED THAT HE WAS NOT RESPONDING TO HIS WIFE, AND SHE GAVE HIM GLUCAGON. THE CUSTOMER STATED THAT THE GLUCAGON DID NOT HELP, AND HIS WIFE CALLED 911. THE CUSTOMER ALSO STATED THAT HE WEARS THE SENSOR, AND DID NOT GET ANY TYPE OF LOW BLOOD GLUCOSE WARNING. ADVISED THE CUSTOMER TO ALWAYS TREAT BASED ON BLOOD GLUCOSE LEVELS, NOT SENSOR GLUCOSE LEVELS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123088 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization