BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4103386 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-25254
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 21, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT NO BUTTON ERROR ALARMS NOTED. MINOR SCRATCHES ON THE LCD WINDOW, CRACKED RESERVOIR TUBE LIP, SCRATCHES ON THE RESERVOIR TUBE WINDOW, CRACKED BATTERY TUBE THREADS, CRACKED BELT CLIP SLOT AND STAINED ADDRESS/SERIAL NUMBER LABEL. THE INSULIN PUMP HAD INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES.

    Description of Event or Problem · 1

    CUSTOMER'S FATHER REPORTED THAT THE INSULIN PUMP RETURNED A BUTTON ERROR ALARM. CUSTOMER'S FATHER DID NOT RECALL ANY SIGNIFICANT EVENTS LEADING UP TO THE ALARM. BLOOD GLUCOSE LEVEL WAS 273 MG/DL AT THE TIME OF THE CALL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585103 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR