BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4190499 · Received October 21, 2014

    Report

    Report Number
    2032227-2014-41282
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    September 23, 2014
    Report Date
    September 23, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. 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 CALLED TO REPORT THE INSULIN PUMP ALARMED FOR MOTOR ERROR DURING THE BOLUS PROCESS. BLOOD GLUCOSE READING WAS 179 MG/DL. TROUBLESHOOTING WAS PERFORMED. CUSTOMER DID NOT RECALL ANY SIGNIFICANT EVENTS LEADING UP TO THE ALARM. THE INSULIN PUMP WAS NOT EXPOSED TO A STRONG MAGNETIC FIELD. CUSTOMER STATED THAT THE INSULIN PUMP WAS ABLE TO COMPLETE THE REWIND SEQUENCE. ADVISED THAT THE INSULIN PUMP WILL BE REPLACED. THE CUSTOMER DECLINED TO RETURN THE OUT OF WARRANTY INSULIN PUMP AT THIS TIME. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666985 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 52 YR