BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4243750 · Received November 11, 2014

    Report

    Report Number
    2032227-2014-50428
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 14, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (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

    CUSTOMER REPORTED EXPERIENCING LOW BLOOD GLUCOSE OF 45 OR 50 MG/DL. CUSTOMER'S CURRENT BLOOD GLUCOSE WAS 207 MG/DL. CUSTOMER STATES SHE HAS BEEN HAVING LOW BLOOD GLUCOSE WITH HER JOB SINCE SHE WAS ALSO TRYING TO LOSE WEIGHT AND CUT DOWN ON CARBOHYDRATES. CUSTOMER ATTEMPTED TO USE AN IV PREP SUPPLIED BY HER DOCTOR BUT IT DID NOT WORK. CUSTOMER HAS BEEN OF THE DEVICE FOR THREE DAYS NOW. CUSTOMER RAN OUT OF QUICK SETS DUE TO SCARRING AND LACK OF ABSORPTION IN THE FRONT ABDOMEN. CUSTOMER DECLINED TROUBLESHOOTING. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726866 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention