BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3972356 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-88702
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    March 15, 2013
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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 CALLED STATING HIS INSULIN PUMP IS DISPLAYING A MESSAGE THAT HE DOES NOT KNOW. CUSTOMER'S BLOOD GLUCOSE WAS 186 MG/DL. IT WAS DETERMINED THAT THE MESSAGE WAS THE AUTO OFF ALARM SET FOR EIGHT HOURS. IT ALSO REVEALED A LOW PREDICT ALARM. THE ALARMS WERE EXPLAINED TO CUSTOMER. CUSTOMER ALSO MENTIONED A LOW BLOOD GLUCOSE EVENT WHERE HE WAS INJURED AND REQUIRED SURGERY. THIS OCCURRED ON (B)(6) 2013. CUSTOMER HAD A HYPOGLYCEMIC EVENT WHERE HE FELL AND INJURED HIS NECK AND BACK. HE REQUIRED SURGERY FOR HIS INJURIES. CUSTOMER DID NOT PROVIDE ANY FURTHER DETAILS AROUND THE INJURY BECAUSE HE HAD JUST TAKEN SLEEPING PILLS AND WAS FALLING ASLEEP. CUSTOMER WAS ADVISED TO CALL BACK WITH MORE INFORMATION WHEN HE FEELS BETTER. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447528 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization