BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSUILN INFUSION PUMP

    MDR report key: 4130360 · Received September 18, 2014

    Report

    Report Number
    2032227-2014-24690
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    August 19, 2014
    Report Date
    August 19, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT NO WEAK BATTERY ALARM OR BATTERY OUT LIMIT NOTED. NO UNEXPECTED SCROLLING NUMBERS DURING TESTING. ALL THE OPERATING CURRENTS WERE WITHIN SPECIFICATION. OFF NO POWER ALARM DID FUNCTION PROPERLY AND THE DEVICE PASSED THE SELF TEST. THE UNIT WAS RECEIVED WITH INTERMITTENT BUTTON RESPONSE DUE TO MOISTURE DAMAGE KEYPAD TRACES, CRACKED CASE AT THE DISPLAY WINDOW CORNER, CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHED LCD WINDOW, CRACKED BELT CLIP SLOT AND CRACKED BATTERY TUBE THREADS

    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. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP HAD SCROLLING NUMBERS WHEN THE CUSTOMER PRESSED THE UP AND DOWN BUTTONS. THE BLOOD GLUCOSE READING WAS 201 MG/DL. THE CUSTOMER ALSO OBSERVED WEAK BATTERY AND BATTERY OUTLIMIT ALARMS. NO SIGNIFICANT EVENTS LEADING TO THE KEYPAD ISSUES WERE OBSERVED. ADVISED REPLACEMENT OF THE INSULIN PUMP. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579968 PARADIGM REAL-TIME REVEL INSUILN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-723LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR