BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3200589 · Received July 1, 2013

    Report

    Report Number
    3004209178-2013-95279
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 12, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    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

    THE CUSTOMER REPORTED EXPERIENCING HIGH BLOOD GLUCOSE AND SHE FEELS THE INSULIN PUMP IS NOT DELIVERING INSULIN. TROUBLESHOOTING WAS PERFORMED. THE PROGRAMMING AND BOLUS WIZARD SETTINGS WERE CORRECT, BUT THE BASAL RATES WERE INACCURATE. THE CUSTOMER MENTIONED THAT SHE IS HAVING SURGERY ON HER HAND, AND DOES NOT KNOW HOW LONG THE SURGERY WILL LAST OR IF SHE WILL HAVE TO DISCONNECT FROM THE INSULIN PUMP. ADVISED THE CUSTOMER THAT THE INSULIN PUMP SHOULD NOT BE WORN DURING X-RAYS, MRIS, OR CAT SCANS. THE CALLER MENTIONED THAT SHE HAS A VIRUS AND USUALLY THAT RAISES HER BLOOD GLUCOSE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298490 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 50 YR