BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4170438 · Received October 14, 2014

    Report

    Report Number
    2032227-2014-37935
    Event Type
    Injury
    Date Received
    October 14, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 15, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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 REPORTED HAVING HIGH BLOOD GLUCOSE. SHE ALSO REPORTED THAT HER INSULIN PUMP WAS NOT DELIVERING INSULIN BASED ON A VISUAL INSPECTION. THE CUSTOMER STATED SHE HAD A BLOOD GLUCOSE OF 473 MG/DL EARLIER IN THE DAY. SHE HAD TREATED WITH 10 UNITS OF INSULIN, BUT HER BLOOD GLUCOSE ONLY DECLINED TO 438 MG/DL. THE CUSTOMER STATED SHE WAS NOT HAVING ANY SYMPTOMS OF HIGH BLOOD GLUCOSE. SHE HAD TREATED HER BLOOD GLUCOSE WITH A MANUAL INJECTION. TROUBLESHOOTING FOUND INSULIN WAS ABLE TO EXIT FROM THE TUBING AND THAT THE CUSTOMER'S CANNULA WAS NOT OCCLUDED. THE CUSTOMER WAS ADVISED TO REPLACE HER INFUSION SET, RESERVOIR, AND INSULIN. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651926 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR