BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4122721 · Received September 18, 2014

    Report

    Report Number
    2032227-2014-24663
    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 Occupation
    OTHER

    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

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS RECEIVED WITH BUTTON ERROR ALARM DUE TO CORRODED KEYPAD TRACES. THE DEVICE HAD MINOR SCRATCHED LCD WINDOW, CRACKED DISPLAY WINDOW CORNER, CRACKED BATTERY TUBE THREADS AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    CUSTOMER'S WIFE REPORTED RECEIVING A BUTTON ERROR ALARM ON THE INSULIN PUMP. CUSTOMER'S WIFE STATED THAT THE ERROR ALARM OCCURRED DURING A RESERVOIR CHANGE. BLOOD GLUCOSE LEVEL AT THE TIME OF THE CALL WAS NOT PROVIDED, BUT CUSTOMER HAD A BLOOD GLUCOSE LEVEL OF 59 MG/DL EARLIER THAT DAY. CUSTOMER TREATED FOR THE LOW BLOOD GLUCOSE LEVEL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579726 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR