BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2234061 · Received August 29, 2011

    Report

    Report Number
    2032227-2011-02196
    Event Type
    Injury
    Date Received
    August 29, 2011
    Date of Event
    August 16, 2011
    Report Date
    August 18, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE WAS TREATED AT THE HOSPITAL FOR A BLOOD GLUCOSE READING OF 32 MG/DL. THE CUSTOMER STATED THAT HER BLOOD GLUCOSE LEVELS WENT LOW BECAUSE SHE IS A VERY BRITTLE DIABETIC. THE CUSTOMER STATED THAT SHE HAS HAD NO ISSUES SINCE BEING RELEASED FROM THE HOSPITAL. THE CUSTOMER HAD PREVIOUSLY CALLED TO REPORT THE NUMBERS RAMPING UP ON THEIR OWN DUE TO A BUTTON THAT GOT STUCK. THE INSULIN PUMP WAS REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization