BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 6091233 · Received November 9, 2016

    Report

    Report Number
    2032227-2016-40890
    Event Type
    Injury
    Date Received
    November 9, 2016
    Date of Event
    November 1, 2016
    Report Date
    November 18, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    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 WAS RECEIVED WITH UNRESPONSIVE ESCAPE AND ACT BUTTONS DUE TO UNLOCKED LCD KEYPAD CONNECTOR. UNABLE TO PERFORM OPERATING CURRENTS, SELF-TEST, A21 ERROR TEST, REWIND TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST, EXCESSIVE NO DELIVERY TEST AND DISPLACEMENT TEST DUE TO UNRESPONSIVE BUTTON. THE INSULIN PUMP HAD MINOR SCRATCHED LCD WINDOW, CRACKED LCD WINDOW, CRACKED CASE AT THE DISPLAY WINDOW CORNERS, CRACKED BATTERY TUBE THREADS AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL OF HIGH BLOOD GLUCOSE READINGS AND A BUTTON ERROR ON THE INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE READING WAS 514 MG/DL. THE CUSTOMER TREATED WITH INJECTION. THE CUSTOMER STATED THAT SHE TRIED TO UNSUSPEND THE PUMP AND THE ACT BUTTON WAS NOT WORKING. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACKUP PLAN PER HEALTH CARE PROVIDER'S INSTRUCTIONS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741692 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Other