BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 5763974 · Received June 30, 2016

    Report

    Report Number
    3004209178-2016-56693
    Event Type
    Injury
    Date Received
    June 30, 2016
    Date of Event
    June 10, 2016
    Report Date
    June 11, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    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 VIA PHONE CALL THAT HIS BLOOD GLUCOSE EXCEEDED 400 MG/DL YESTERDAY, WHICH HE TREATED WITH A MANUAL INSULIN INJECTION. THE CUSTOMER DID NOT FEEL ANY SYMPTOMS OF HIGH BLOOD GLUCOSE. TROUBLESHOOTING WAS INITIATED TO INSPECT THE DEVICE. THE DRIVE SUPPORT CAP APPEARED NORMAL. HOWEVER, THE CUSTOMER DECLINED TO CHECK THEIR BOLUS HISTORY. THE ALARM HISTORY CONFIRMED A NO DELIVERY ALARM; THE CUSTOMER DID HAVE A BENT CANNULA YESTERDAY. THERE WAS ALSO WHAT APPEARED TO BE A SMALL AIR BUBBLE IN THE CURRENT INFUSION SET TUBING. A MANUAL PRIME WAS RUN SUCCESSFULLY AS INSULIN EXITED AT THE QR. A HIGH PRESSURE TEST COULD NOT BE PERFORMED DUE TO LACK OF A TUBING CLAMP. NO PRODUCTS WERE RETURNED OR REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418249 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other