BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4120069 · Received September 25, 2014

    Report

    Report Number
    2032227-2014-29382
    Event Type
    Injury
    Date Received
    September 25, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4). 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

    CUSTOMER REPORTED SHE WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE OF 348 MG/DL. CUSTOMER SYMPTOMS WERE DIARRHEA, ABDOMINAL CRAMPS, VOMITING, AND THIRSTY. TROUBLESHOOTING WAS PERFORMED. THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER REMOVED INFUSION SET. NO LEAKS OR AIR BUBBLES NOTED. MANUAL PRIME WAS PERFORMED ON THE DEVICE AND INSULIN DID EXIT. SETTINGS WERE REVIEWED AND WERE CORRECT. CUSTOMER STATED THE CANNULA WAS NOT OCCLUDED. CUSTOMER STATED THAT SHE HAD INSERTED HER INFUSION SET ON SATURDAY AND STATED THAT HER SITE WAS SORE. CUSTOMER WAS ADVISED THAT SORENESS AT THE SITE WAS AN INDICATION THAT THE SITE MIGHT BE BENT OR OCCLUDED. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597963 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Hospitalization