BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3122943 · Received May 21, 2013

    Report

    Report Number
    2032227-2013-02023
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 27, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    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 CALLED TO REPORT THAT HE WAS HOSPITALIZED WITH BLOOD GLUCOSE LEVELS GREATER THAN 600 MG/DL, AND NEEDED ASSISTANCE PROGRAMMING THE INSULIN PUMP. THE CUSTOMER STATED THAT HE WAS USING DENATURED INSULIN. THE CUSTOMER EXPERIENCED NAUSEA, VOMITING, EXCESSIVE THIRST, FREQUENT URINATION AND IRRITABILITY. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE PRIME TEST, BUT THERE WAS NO TUBING CLAMP FOR THE HIGH PRESSURE TEST. THE TUBING CLAMP WAS SHIPPED TO THE CUSTOMER. THE CUSTOMER LATER CALLED TO CONDUCT THE HIGH PRESSURE TEST, BUT ONLY WANTED TO SPEAK WITH THE INITIAL REPRESENTATIVE HE SPOKE TO. OFFERED TO ASSIST, BUT HE DECLINED. TRANSFERRED TO THE PREVIOUS REPRESENTATIVE TO LEAVE A MESSAGE SINCE SHE WAS NOT AVAILABLE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223662 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization