BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 6011205 · Received October 7, 2016

    Report

    Report Number
    2032227-2016-28516
    Event Type
    Injury
    Date Received
    October 7, 2016
    Date of Event
    September 4, 2016
    Report Date
    October 4, 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
    KY
    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. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL OF HIGH BLOOD GLUCOSE READINGS, BUTTON ERROR, MOTOR ERROR, DELIVERY ANOMALY, BOLUS ANOMALY, PRIME ANOMALY AND LOW BATTERY ALERT FROM THE INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE READING WAS 581 MG/DL. THE CUSTOMER REPORTED THAT THE BUTTONS WERE UNRESPONSIVE, AND THE BASAL SETTINGS RESET ON THEIR OWN AND IT'S NOT CORRECT. THE CUSTOMER STATED THAT SHE REPLACED HER BATTERIES MORE FREQUENTLY DUE TO DIMINISHED BATTERY LIFE. THE CUSTOMER REPORTED MOTOR ERROR DURING REWIND. THE CUSTOMER DECLINED TO TROUBLESHOOT FOR HIGH READINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662962 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 67 YR Other