BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 6132508 · Received November 29, 2016

    Report

    Report Number
    2032227-2016-46325
    Event Type
    Injury
    Date Received
    November 29, 2016
    Date of Event
    November 1, 2016
    Report Date
    December 12, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE FUNCTIONAL TESTING, INCLUDING THE OPERATING CURRENTS MEASUREMENT, SELF-TEST, UNEXPECTED ERROR TEST, DISPLACEMENT TEST, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME AND EXCESSIVE NO DELIVERY TEST. THE INSULIN PUMP HAD CRACKED CASE AT DISPLAY WINDOW CORNERS, BATTERY TUBE THREADS, MINOR SCRATCHED AND CRACKED DISPLAY WINDOW. THE DRIVE SUPPORT DISK WAS INSPECTED AND NO ANOMALY WAS NOTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED VIA PHONE CALL INDICATING THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE OF 400 MG/DL DUE TO A BENT CANNULA. THE CUSTOMER WAS TREATED FOR THE HIGH BLOOD GLUCOSE WITH MANUAL INJECTIONS. CUSTOMER REPORTS THE DRIVE SUPPORT CAP IS FLUSH. THE CUSTOMER RETURNED THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782487 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 62 YR Other