BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4211946 · Received October 29, 2014

    Report

    Report Number
    2032227-2014-45366
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    June 30, 2014
    Report Date
    September 30, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    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. 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.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP HAD A BLANK DISPLAY DUE TO CORRODED BATTERY TUBE AND BATTERY CAP CONTACT. NO LOW BATTERY, WEAK BATTERY, FAILED BATTERY TEST, OR OFF NO POWER ANOMALIES COULD BE VERIFIED DUE TO THE BLANK DISPLAY. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED CASE AT THE DISPLAY WINDOW CORNERS AND MINOR SCRATCHES ON THE DISPLAY WINDOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP HAD A FAILED BATTERY TEST AND AN OFF/NO POWER ALERT. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 102 MG/DL. THE CUSTOMER HAD BEEN HAVING BATTERY ISSUES FOR THREE MONTHS. STANDARD TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER DOES NOT USE THE RECOMMENDED BATTERY. THE PRODUCT HAS BEEN RETURNED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692969 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR