BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4213260 · Received October 13, 2014

    Report

    Report Number
    2032227-2014-37252
    Event Type
    Malfunction
    Date Received
    October 13, 2014
    Date of Event
    September 13, 2014
    Report Date
    September 13, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED BUT NOT YET EVALUATED AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THIS MDR RELATED TO THE PUERTO RICO MFG SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD A BATTERY OUT LIMIT ALARM ON HER INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 151 MG/DL. CUSTOMER STATED THAT THE KEYS WILL NOT DO ANYTHING. CUSTOMER STATED THAT THE ALARM OCCURRED AFTER THE BATTERY CHANGE. PUMP WAS ALARMING AT THE TIME OF THE CALL. CUSTOMER WILL CALL DOCTOR'S OFFICE FOR SETTING INFO AND THEN WILL CALL MEDTRONIC BACK. CUSTOMER WAS OFFERED TROUBLESHOOTING FOR THE PUMP, BUT THE CUSTOMER DECLINED. NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648705 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC PUERTO RICO OPERATIONS CO MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR