BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4790668 · Received May 22, 2015

    Report

    Report Number
    3004209178-2015-58336
    Event Type
    Injury
    Date Received
    May 22, 2015
    Date of Event
    May 1, 2015
    Report Date
    May 1, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    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.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED AND REPORTED RECEIVING NO DELIVERY ALARMS ON THE INSULIN PUMP, RESOLVED WITH AN INFUSION SET CHANGE. DURING THE CALL, CUSTOMER MENTIONED HER BLOOD GLUCOSE WOULD GO LOW EVERY MORNING AROUND 42 MG/DL, WHICH SHE WOULD CORRECT BY EATING A CANDY BAR. CUSTOMER STATED SHE HAD PASSED OUT ONCE BEFORE BUT REFUSED TROUBLESHOOTING FOR BOTH LOW AND HIGH BLOOD GLUCOSE. CUSTOMER AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335694 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR