BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4240497 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-34164
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    October 11, 2014
    Report Date
    October 11, 2014
    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
    OTHER

    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED A NO DELIVERY ALARM AND EXPERIENCED A BLOOD GLUCOSE OF 516 MG/DL. THE CUSTOMER STATED THAT HE RECEIVED THE NO DELIVERY ALARM BECAUSE HE HAD AN EMPTY RESERVOIR AND WAS OUT OF INSULIN. THE CUSTOMER FILLED A NEW RESERVOIR AND PLACED IT IN THE INSULIN PUMP. HE THEN HAD DIFFICULTY GETTING THE INSULIN PUMP TO PRIME, STATING THAT PRESSING THE ACT BUTTON WOULD NOT PUSH INSULIN INTO THE TUBING. IT BEGAN TO WORK AFTER REWINDING THE INSULIN PUMP AGAIN AND INSULIN CAME OUT, AFTER THE CUSTOMER CLEARED A WEAK SIGNAL ALARM. ASSISTANCE WAS PROVIDED WITH USING THE BOLUS WIZARD. THE CUSTOMER DECLINED FURTHER TROUBLESHOOTING, IN ORDER TO FOCUS ON LOWERING HIS BLOOD GLUCOSE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723558 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR