BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3230553 · Received July 16, 2013

    Report

    Report Number
    3004209178-2013-95773
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 24, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    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. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS. THE DEVICE HAD CRACKED CASE NEAR THE DISPLAY WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP, AND CRACKED BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING IN THE EMERGENCY ROOM DUE TO DIABETES KETOACIDOSIS AND HIGH BLOOD GLUCOSE OF 820MG/DL. THE CUSTOMER STATED THAT HIS GLUCOSE LEVEL WAS HIGH ALL DAY AND HAD CHANGED THE INFUSION SET, BUT IT DID NOT DROP. THE CUSTOMER ALSO MENTIONED HAVING ISSUES WITH LOW BATTERY LATELY. THE CALLER STATED THAT THE INSULIN PUMP HAS CRACKS ON THE BATTERY COMPARTMENT. TROUBLESHOOTING WAS DECLINED AS CUSTOMER REQUESTED A REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328217 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Hospitalization