BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2902439 · Received January 8, 2013

    Report

    Report Number
    3004209178-2013-90118
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    December 22, 2012
    Report Date
    December 23, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INTERMITTENT BUTTON PRESS NOTED DURING TESTING DUE TO CORRODED KEYPAD TRACES. THE INSULIN PUMP WAS RECEIVED WITH SEVERELY SCRATCHED LCD WINDOW, SCRATCHES AROUND CASING AND CRACKED BATTERY TUBE THREADS. ALL OPERATING CURRENTS ARE WITHIN SPECIFICATION. NO UNEXPECTED FAILED BATTERY TEST ALARMS NOTED. THE INSULIN PUMP PASSED FUNCTIONAL TEST INCLUDING DISPLACEMENT TEST, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME AND EXCESSIVE NO DELIVERY ALARM TEST. THE INSULIN PUMP FUNCTIONED PROPERLY.

    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING IN THE EMERGENCY ROOM DUE TO HIGH BLOOD GLUCOSE OVER 800MG/DL. INITIALLY, THE CUSTOMER CALLED REGARDING THE FAILED BATTERY TEST. TROUBLESHOOTING WAS PERFORMED. ADVISED THE CUSTOMER TO WAIT FIVE SECONDS BEFORE INSERTING THE NEW BATTERY. THE CALLER STATED THAT THE DEVICE ALARMED FAILED BATTERY TEST. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9574 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Hospitalization