BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4142288 · Received October 5, 2014

    Report

    Report Number
    2032227-2014-33445
    Event Type
    Injury
    Date Received
    October 5, 2014
    Date of Event
    August 7, 2014
    Report Date
    September 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4). 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 EXPERIENCED HIGH BLOOD GLUCOSE LEVELS AND OBSERVED AIR BUBBLES DURING INSULIN PUMP THERAPY. THE BLOOD GLUCOSE READING WAS 400 MG/DL. THE CUSTOMER NOTED FLUCTUATING BLOOD GLUCOSE READINGS RANGING BETWEEN 135 MG/DL TO 400 MG/DL. SHE STATED THAT HER DOCTOR ADVISED THAT SOMETHING WAS WRONG AND CHANGED HER BASAL SETTINGS; SHE NOTED THAT THIS HAD IMPROVED HIS CONDITION BUT STILL OBSERVED AIR BUBBLES. SHE REQUESTED REPLACEMENT OF THE INSULIN PUMP, DECLINING TROUBLESHOOT FOR HIGH BLOOD GLUCOSE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622081 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR