BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4061177 · Received September 4, 2014

    Report

    Report Number
    2032227-2014-16774
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Date of Event
    August 4, 2014
    Report Date
    August 5, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    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 AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARMED MOTOR ERROR DURING REWIND DUE TO CORRODED MOTOR HOME SWITCH. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO REWIND ANOMALY. THE INSULIN PUMP HAD MINOR SCRATCHES ON THE DISPLAY WINDOW, CRACKED BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE LIP, AND SCRATCHED CASE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A MOTOR ERROR ON HIS INSULIN PUMP. HE SAID LAST NIGHT HE RECEIVED A MOTOR ERROR, HE REWOUND THE DEVICE, AND THEN HE RECEIVED A NO DELIVERY ALARM. CUSTOMER'S BLOOD GLUCOSE WAS 420 MG/DL. THERE WERE NO SIGNIFICANT EVENTS LEADING TO THE ALARM. THE DEVICE WAS NOT EXPOSED TO A STRONG MAGNETIC FIELD. THE ALARM WAS CLEARED. CUSTOMER DOES NOT USE THE SENSOR FEATURE. CUSTOMER IS UNABLE TO REWIND THE DEVICE. CUSTOMER WAS ADVISED THAT THE DEVICE NEEDS TO BE REPLACED, AND TO DISCONTINUE USE AND REVERT TO A BACK UP PLAN. CUSTOMER'S CURRENT BLOOD GLUCOSE IS 260 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541186 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention