BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2973109 · Received February 21, 2013

    Report

    Report Number
    3004209178-2013-91229
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 8, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE OF 387MG/DL. THE CUSTOMER EXPERIENCED KETONES, THIRST, AND VOMITING. TROUBLESHOOTING WAS PERFORMED. THE MOTHER STATED THAT THE CANNULA WAS BENT. THE TIME AND DATE WERE INCORRECT. ASSISTED THE MOTHER WITH CORRECTING THEM. THE BASAL RATES AND BOLUS WIZARD SETTINGS WERE CORRECT. REVIEWED THE ALARM HISTORY AND FOUND NO DELIVERY, BATTERY AND RESERVOIR ALARMS. THE CALLER STATED THAT THE DRIVE SUPPORT CAP WAS FLUSH. ASSISTED THE MOTHER TO RUN A MANUAL PRIME TEST AND THE INSULIN DID EXIT. IT WAS ALSO MENTIONED THAT HER BLOOD GLUCOSE READS DIFFERENT FROM THE HOSPITAL'S BLOOD GLUCOSE METER. ADVISED THE MOTHER TO CALL BACK WHEN THE TUBING CLAMP ARRIVES TO CONTINUE TESTING. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76833 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Hospitalization