BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3211964 · Received July 8, 2013

    Report

    Report Number
    3004209178-2013-95471
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    June 15, 2013
    Report Date
    June 17, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING INCLUDING THE DISPLACEMENT TEST. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS. UNABLE TO CONFIRM LOW BATTERY ALARMS. THE DEVICE WAS RECEIVED WITH CRACKED BATTERY TUBE THREADS AND RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE. THE CALLER STATED THAT HER INSULIN PUMP ALARMED LOW BATTERY AND STARTED MAKING A BEEPING NOISE BEFORE HER ADMISSION. THE BATTERY WAS CHANGED THREE TIMES, BUT THE DEVICE ALARMED AGAIN. DURING THE CALL, THE CUSTOMER STATED THAT SHE WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE OF 1000MG/DL. THE CALLER STATED THAT WHEN SHE WOKE UP SHE FELL VERY SICK AND COULD NOT CATCH HER BREATH. THEN THE PARAMEDICS WERE CALLED AND THEY TOOK HER TO THE HOSPITAL. TROUBLESHOOTING WAS DECLINED AS CUSTOMER REQUESTED A REPLACEMENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310263 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization