BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3972239 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-88653
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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

    ALL OPERATING CURRENTS ARE WITHIN SPECIFICATION. THE INSULIN PUMP PASSED THE DISPLACEMENT TEST, SELF TEST AND A21 ERROR TEST. NO A21 ALARMS WERE NOTED. THE INSULIN PUMP FUNCTIONED PROPERLY. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON THE DISPLAY WINDOW AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN A21 ALARM. PRIOR TO THE EVENT, THE PATIENT STATED THAT SHE TRIED TO CLEAR IT BUT THE DEVICE WENT BACK TO THE ALARM. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS STORED AND WAS NOT IN USE FOR AN EXTENDED PERIOD OF TIME. THE CURRENT BLOOD GLUCOSE LEVEL IS 334 MG/DL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448200 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR