BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4141827 · Received October 4, 2014

    Report

    Report Number
    2032227-2014-33608
    Event Type
    Injury
    Date Received
    October 4, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 4, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. 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 LOW BLOOD GLUCOSE LEVELS. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 59 MG/DL. CUSTOMER STATED THAT SHE'S BEEN HAVING LOWS EVERY MORNING AND THAT HER DOCTOR DID A DIFFERENT CARB RATION. CUSTOMER STATED THAT SHOULD JUST CHANGE OUT THE PUMP BASED ON THE DOCTOR'S DECISION. CUSTOMER STATED THAT SHE CAN HANDLE LOWS DOWN TO 26 MG/DL. CUSTOMER DOES NOT WANT TO TROUBLESHOOT THE PUMP AT ALL AND WANTS THE PUMP REPLACED BECAUSE THOSE WERE THE DOCTOR'S ORDERS. CUSTOMER HAD CANDY CORN AND PEANUT BUTTER AND JAM SINCE THAT USUALLY HELPS AS TREATMENT. CUSTOMER STATED THAT THE PUMP WAS EXPOSED TO AN MRI. PUMP PASSED DISPLACEMENT TEST. CUSTOMER WAS ADVISED TO MONITOR THE PUMP AND CALL BACK IF ISSUES PERSIST. CUSTOMER NEEDS TO SPEAK WITH HEALTH CARE PROFESSIONAL REGARDING SETTINGS THAT NEED TO BE ADJUSTED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621710 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523RNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR