BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4183100 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-40088
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    July 19, 2014
    Report Date
    September 19, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR RELATED TO THE (B)(4) 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 THAT THE INSULIN PUMP ALARMED SEVERAL NO DELIVERY ALARMS OVER THE PAST 2 MONTHS. THE BLOOD GLUCOSE READING WAS 400 MG/DL, AND THE CUSTOMER TREATED WITH THE INSULIN PUMP. HE DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE, AS THIS EVENT OCCURRED A FEW WEEKS PRIOR TO THE CALL. THE MOST RECENT BLOOD GLUCOSE READING WAS 175 MG/DL. UPON TROUBLESHOOTING FOR NO DELIVERY, IT WAS FOUND THAT THE INSERTION SITE MAY HAVE BEEN OCCLUDED. ADVISED THE CUSTOMER TO CHANGE THE ENTIRE INFUSION SET AND TO RETURN THE INFUSION SET FOR ANALYSIS. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660626 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR UNOMEDICAL PRODUCT