BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2870054 · Received December 12, 2012

    Report

    Report Number
    2032227-2012-07989
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    November 21, 2012
    Report Date
    November 21, 2012
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 CALLER REPORTED THAT THE CUSTOMER WAS HOSPITALIZED ABOUT A MONTH AGO DUE TO HIGH BLOOD GLUCOSE LEVELS, BUT THE CUSTOMER NEVER REPORTED THE EVENT. IT WAS REPORTED THAT THE CUSTOMER'S BLOOD GLUCOSE LEVELS WERE 300 MG/DL WHEN SHE WAS RELEASED, BUT HER DOCTOR DID NOT FEEL THAT THE INSULIN PUMP WAS AT FAULT. THE CALLER STATED THAT HE ADVISED THE CUSTOMER TO REPORT ANY HOSPITALIZATION OR PRODUCT RELATED CONCERN IN THE FUTURE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC OYC MEDTRONIC MINIMED MMT-523LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization