BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3920032 · Received July 8, 2014

    Report

    Report Number
    3004209178-2014-86491
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 16, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    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 BY THE CUSTOMER THAT SHE HAD BEEN HOSPITALIZED FOR LOW BLOOD GLUCOSE LEVELS ON (B)(6) 2014. CUSTOMER WAS NINE WEEKS PREGNANT AT TIME OF HOSPITALIZATION. BLOOD GLUCOSE LEVEL AT TIME OF HOSPITALIZATION WAS 42 MG/DL. CUSTOMER WAS PROVIDED WITH BLOOD GLUCOSE MONITORING EDUCATION DURING ADMISSION. ATTEMPTED TO TROUBLESHOOT FURTHER BUT CUSTOMER DECLINED AND STATED SHE BELIEVED THE INSULIN PUMP HAD BEEN FUNCTIONING PROPERLY. INFORMED CUSTOMER ABOUT HER BOLUS SETTING AND HOW THEY WOULD AFFECT HER INSULIN DELIVERY. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 316 MG/DL AT TIME OF REPORTING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397040 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Hospitalization