BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3883692 · Received June 19, 2014

    Report

    Report Number
    2032227-2014-03069
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    May 24, 2014
    Report Date
    May 24, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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 RETURN FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP RECEIVED WITH INTERMITTENT BUTTON RESPONSE AND BUTTON ERROR ALARM DUE TO CORRODED KEYPAD TRACES. THE INSULIN PUMP PASSED DISPLACEMENT TEST, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME AND NO DELIVERY TESTS. THE INSULIN PUMP HAD CRACKED DISPLAY WINDOW CORNER, CRACKED LCD WINDOW, SCRATCHED LCD WINDOW, CRACKED RESERVOIR TUBE LIP AND MISSING END CAP STICKER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT SHE IS IN HER WAY TO THE EMERGENCY ROOM BECAUSE SHE HAD HIGH BLOOD GLUCOSE. CUSTOMER BLOOD GLUCOSE READING WAS 413 MG/DL. CUSTOMER STATED THAT HER INSULIN PUMP STOP WORKING EARLIER AND HER BLOOD GLUCOSE IS HIGH. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360325 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization