BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3974335 · Received August 1, 2014

    Report

    Report Number
    3004209178-2014-88868
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    June 30, 2014
    Report Date
    July 2, 2014
    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 FAMILY MEMBER OR FRIEND

    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 WAS HOSPITALIZED. CUSTOMER STATED THAT SHE HAD A SEIZURE AND WAS TAKEN TO THE EMERGENCY ROOM. CUSTOMER STATED THAT PREVIOUS TO THE EVENT; SHE MIGHT HAVE EXPERIENCED LOW BLOOD GLUCOSE WHEN WAKING UP BUT DID NOT TEST TO CHECK THE VALUE. SHE STATED SHE ATE TO TREAT THE LOW BLOOD GLUCOSE AND AT THE TIME OF THE SEIZURE, THE BLOOD GLUCOSE CAME UP TO 113 MG/DL. CUSTOMER IS UNSURE IF THE SEIZURE WAS CAUSED BY LOW BLOOD GLUCOSE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451313 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Hospitalization