BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3873324 · Received June 13, 2014

    Report

    Report Number
    3004209178-2014-85725
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 26, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND 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 CALLED IN TO REPORT THAT SHE HAD BEEN HOSPITALIZED FOR HIGH BLOOD SUGAR LEVELS AND DIABETIC KETOACIDOSIS. THE SYMPTOMS OF HIGH BLOOD SUGAR LEVELS THAT THE CUSTOMER EXPERIENCED WERE NAUSEA AND WEAKNESS. THE CUSTOMER'S BLOOD GLUCOSE IS UNKNOWN. TROUBLESHOOTING WAS PERFORMED ON THE DEVICE AND IT WAS FOUND THAT, DURING THE MANUAL PRIME, INSULIN DID EXIT FROM THE DEVICE. THE TIME AND DATE ON THE DEVICE WAS CORRECT. THE BASAL RATES AND BOLUS WIZARD SETTINGS WERE CORRECT. THE CUSTOMER'S BOLUS HISTORY FOR THE DEVICE WAS ACCURATE AS WELL. THE CALLER STATES THAT HER HIGH BLOOD SUGAR LEVELS ONLY HAPPENS AT NIGHT AND ARE PERFECTLY FINE DURING THE DAY. SHE FEELS THE DEVICE IS WORKING ACCORDINGLY. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349077 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization