BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4183176 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-40085
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 19, 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
    WA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP POWERED UP PROPERLY AFTER BATTERY INSTALLATION AND HAD OPERATING CURRENTS WITHIN SPECIFICATION. THE INSULIN PUMP WAS MONITORED AND NO BLANK DISPLAY OR BATTERY ALARMS WERE NOTED. HOWEVER, THE INSULIN PUMP HAD A CORRODED BATTERY TUBE AND BATTERY CAP CONTACT. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON THE DISPLAY WINDOW.

    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

    IT WAS REPORTED THAT THE CUSTOMER HAD AN ISSUE WITH THE BATTERY DYING EVERY DAY. CUSTOMER STATED THAT SHE ALSO GETS A BLANK DISPLAY AND A BATTERY OUT LIMIT ALARM. CUSTOMER REVIEWED THE BATTERY INDICATOR TO CONFIRM THE LOW BATTERY. BATTERY INDICATOR DOES NOT SHOW LESS THAN 2 BARS. CUSTOMER'S BATTERY DID LAST MORE THAN 1 WEEK. CUSTOMER DOES NOT WEAR THE SENSOR. REPLACEMENT BATTERY CAP WILL BE SHIPPED TO THE CUSTOMER. CUSTOMER DID NOT WANT TO TROUBLESHOOT FOR THE BATTERY OUT LIMIT ALARM OR BLANK DISPLAY. CUSTOMER CALLED BACK LATER AFTER RECEIVING THE BATTERY CAP AND STATED THAT THE PUMP WORKED FOR A FEW DAYS. CUSTOMER STATED THAT AFTER THAT, THE PUMP WOULD JUST GO OFF. CUSTOMER STATED THAT SHE HAS TRIED THREE DIFFERENT BATTERIES AND IT IS STILL CUT OFF. INSULIN PUMP WILL NEED TO BE REPLACED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660938 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR