BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4201287 · Received October 27, 2014

    Report

    Report Number
    2032227-2014-42858
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 25, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    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

    THE INSULIN PUMP HAD INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARM WAS NOTED DURING TESTING. THE INSULIN PUMP HAD NORMAL OPERATING CURRENTS AND NO UNEXPECTED FAILED BATTERY ALARMS, NUMBER RAMPING, OR FROZEN DISPLAY WAS NOTED DURING TESTING. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED RESERVOIR TUBE LIP, A CRACKED CASE AT THE DISPLAY WINDOW CORNER, MINOR SCRATCHES ON THE DISPLAY WINDOW, A SCRATCHED RESERVOIR TUBE WINDOW AND A CRACKED BELT CLIP SLOT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED BUTTON ERROR AND BUTTONS WERE UNRESPONSIVE. CUSTOMER STATED THAT HE WAS PROGRAMMING A BOLUS AND NOTICED THAT NUMBERS KEPT SCROLLING. HE TOOK OUT THE BATTERY AND GOT BAD BATTERY ALARM. CUSTOMER INSERTED NEW BATTERY AND GOT FROZEN DISPLAY. TROUBLESHOOTING WAS DONE. CUSTOMER'S BLOOD GLUCOSE WAS 109 MG/DL. ADVISED CUSTOMER THE INSULIN PUMP WOULD BE REPLACED. ADVISED TO DISCONTINUE USING THE PUMP AND REVERT TO A BACK-UP PLAN PER HEALTH CARE PROVIDER. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682894 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR