BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4143730 · Received October 6, 2014

    Report

    Report Number
    2032227-2014-33749
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    August 25, 2014
    Report Date
    September 5, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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 A CORRODED BATTERY TUBE. NO FAILED BATTERY TEST ALARM OR LOW BATTERY ALERTS COULD BE VERIFIED DUE TO THE BLANK DISPLAY. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED CASE AT A DISPLAY WINDOW CORNER, CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHES ON THE DISPLAY WINDOW, A CRACKED RESERVOIR TUBE AND CRACKED BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN PUMP HAD A BLANK DISPLAY AND A CRACKED BATTERY COMPARTMENT. CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP'S BATTERIES DID NOT LAST MORE THAN A FEW DAYS. BLOOD GLUCOSE LEVEL WAS NOT PROVIDED. TROUBLESHOOTING SHOWED THAT THE BATTERY LIFE WAS SHORTENED DUE TO A DAMAGED BATTERY CAP. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623656 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR