BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4111460 · Received September 23, 2014

    Report

    Report Number
    2032227-2014-27617
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 25, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM
    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

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP ALARMED BUTTON ERROR DUE TO MOISTURE DAMAGE ON THE KEYPAD TRACES. THE DEVICE WAS RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW, CRACKED CASE AT THE DISPLAY WINDOW CORNERS, CRACKED BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE LIP AND MISSING END CAP STICKER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED BUTTON ERROR. BLOOD GLUCOSE VALUE IS 61 MG/DL. CUSTOMER STATED THAT THE LOW BLOOD GLUCOSE IS DUE TO BEING ACTIVE AND WORKING IN THE ATTIC; CUSTOMER DID TAKE SOMETHING TO BRING IT UP. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589796 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAB A000202989

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR