BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4182598 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-39853
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    May 1, 2014
    Report Date
    September 19, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. 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

    CUSTOMER'S MOTHER REPORTED A MOTOR ERROR ON CUSTOMER'S INSULIN PUMP DURING BOLUS. CUSTOMER'S BLOOD GLUCOSE HAS ALSO BEEN HIGHER LATELY. CUSTOMER'S BLOOD GLUCOSE WAS 250 MG/DL. THERE WERE NO SIGNIFICANT EVENTS LEADING TO THE ALARM. THE DEVICE WAS NOT EXPOSED TO A STRONG MAGNETIC FIELD. THE ALARM WAS CLEARED. CUSTOMER DOES NOT USE THE SENSOR FEATURE. CUSTOMER'S MOTHER CALLED BACK A DAY LATER AND REPORTED THE DEVICE ALARMED MOTOR ERROR AGAIN. SHE WAS ADVISED THAT THE DEVICE NEEDS TO BE REPLACED, AND TO DISCONTINUE USE AND REVERT TO A BACK UP PLAN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660766 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR