BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3100676 · Received May 8, 2013

    Report

    Report Number
    2032227-2013-01751
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    October 15, 2012
    Report Date
    April 12, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAS BEEN EXPERIENCING LOW BLOOD GLUCOSE. CUSTOMER STATED THAT FIRE DEPARTMENT WAS CALLED TO HOME DUE TO LOW BLOOD GLUCOSE. CUSTOMER WAS HALLUCINATING AND HAD A SEIZURE. CUSTOMER STATED THAT THE INSULIN PUMP WAS NOT WORKING CORRECTLY. REVIEWED PRIMING TECHNIQUE, PRIMING IS CORRECT. THE INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200772 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization