BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4143439 · Received September 27, 2014

    Report

    Report Number
    2032227-2014-30063
    Event Type
    Injury
    Date Received
    September 27, 2014
    Date of Event
    August 29, 2014
    Report Date
    August 29, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CURRENTLY IT IS UNK 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 HAD HIGH BLOOD GLUCOSE LEVELS AND WANTED TO MAKE SURE HER INSULIN PUMP WAS WORKING. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 478 MG/DL. CUSTOMER TREATED WITH MANUAL INJECTIONS. CUSTOMER HAD TROUBLE BREATHING AND SEEING. CUSTOMER CONTACTED THEIR HEALTH CARE PROFESSIONAL FOR HIGH BLOOD GLUCOSE LEVELS. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE PRIME TEST. IT WAS EXPLAINED THAT HIGH BLOOD GLUCOSE LEVELS ARE OFTEN CAUSED BY SITE/SET ISSUES. CUSTOMER WILL CALL BACK WHEN SHE GETS HOME TO FIND BLUE TUBING CLAMPS TO COMPLETE HIGH PRESSURE TESTS FOR TROUBLESHOOTING. NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603557 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-723LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention