BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAS

    MDR report key: 4200545 · Received September 17, 2014

    Report

    Report Number
    2032227-2014-23823
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Date of Event
    August 4, 2014
    Report Date
    August 18, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNK 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 WAS PROGRAMMED WITH THE CORRECT TIME AND DATE AND THEN MONITORED. NO UNEXPECTED ALARMS WERE NOTED DURING TESTING. THE ALARM HISTORY SCREEN WAS VERIFIED AND NO ALARMS WERE LISTED AT THOSE TIMES. THE INSULIN PUMP WAS MONITORED AND NO AUDIO ANOMALY WAS NOTED DURING TESTING. THE INSULIN PUMP PASSED THE SELF TEST. THE INSULIN PUMP HAD MINOR SCRATCHES ON THE DISPLAY WINDOW, A CRACKED CASE NEAR THE DISPLAY WINDOW CORNERS, CRACKED BATTERY TUBE THREADS, A CRACKED RESERVOIR TUBE LIP AND A CRACKED RESERVOIR TUBE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ISSUES WITH THE INSULIN PUMP. CUSTOMER STATES THAT THERE IS A BEEP ANOMALY AND THE INSULIN PUMP IS ALARMING. CUSTOMER STATES THAT THE INSULIN PUMP IS NOT FUNCTIONING ACCURATELY. THE BLOOD GLUCOSE READING IS 270 MG/DL. THE INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575374 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAS OYC MEDTRONIC MINIMED MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR