BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3833506 · Received May 27, 2014

    Report

    Report Number
    3004209178-2014-85015
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    May 4, 2014
    Report Date
    May 9, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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

    CUSTOMER REPORTED THAT SHE WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE LEVEL AND DIABETIC KETOACIDOSIS. AT ARRIVAL OF HOSPITALIZATION CUSTOMER'S HIGH BLOOD GLUCOSE LEVEL WAS 611 MG/DL. CUSTOMER'S SYMPTOMS WERE NAUSEA AND VOMITING. DURING TROUBLESHOOTING CUSTOMER REPORTED THAT SHE HAD EXCESSIVE NO DELIVERY ALARMS THE DAY BEFORE THE EVENT. BLOOD GLUCOSE LEVEL WAS 278 MG/DL WHEN REPORTING. NO FURTHER INFORMATION TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310221 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization