BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2902441 · Received January 8, 2013

    Report

    Report Number
    3004209178-2013-90120
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    December 23, 2012
    Report Date
    December 24, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING INCLUDING THE DISPLACEMENT TEST. THE DEVICE HAD SCRATCHED DISPLAY WINDOW, BROKEN BELT CLIP SLOT, AND CRACKED RESERVOIR TUBE. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING IN THE EMERGENCY ROOM DUE TO HIGH BLOOD GLUCOSE OF 487MG/DL. THE CUSTOMER EXPERIENCED TROUBLE BREATHING, NAUSEA, AND DEHYDRATION. TROUBLESHOOTING WAS PERFORMED. ASSISTED THE CALLER TO RUN A HIGH PRESSURE TEST AND THE TEST PASSED. THE CUSTOMER MENTIONED THAT SHE WAS IN A CAR ACCIDENT TWO DAYS BEFORE HER ADMISSION, AND SHE WAS THE DRIVER. THE CUSTOMER STATED THAT SHE WAS DISCONNECTED FROM THE INSULIN PUMP PER DOCTOR'S INSTRUCTIONS, AND THE DEVICE WAS DAMAGED AT THE RESERVOIR COMPARTMENT DURING THE ACCIDENT. ADVISED THE CUSTOMER TO DISCONTINUE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9327 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 55 YR Hospitalization