BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3962133 · Received July 28, 2014

    Report

    Report Number
    2032227-2014-04867
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    MEDTRONIC MINIMED
    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

    THE INSULIN PUMP PASSED THE DISPLACEMENT, REWIND, BASIC OCCLUSION. OCCLUSION, PRIME AND EXCESSIVE NO DELIVERY TESTS. THE INSULIN PUMP PASSED THE SELF TEST. NO UNEXPECTED DISPLAY ANOMALY WAS NOTED. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED DISPLAY WINDOW CORNER, CRACKED RESERVOIR TUBE LIP AND MINOR SCRATCHES ON THE DISPLAY WINDOW.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS EXPERIENCING HIGH BLOOD GLUCOSE OF OVER 600 MG/DL DUE TO THE INSULIN PUMP NOT DELIVERING ENOUGH INSULIN. THE CUSTOMER STATED THAT THE DAY BEFORE THE PHONE CALL THEIR BLOOD GLUCOSE WAS OVER 300 MG/DL. THE CUSTOMER STATED THAT THEY DO NOT BELIEVE THE INSULIN PUMP GAVE THE CORRECT AMOUNT OF INSULIN. THE CUSTOMER HAD FREQUENT URINATION. THE CUSTOMER TREATED WITH MANUAL INJECTION. IN THE ALARM HISTORY OF THE DEVICES THERE WAS AN ALARM PRESENT FOR LOW RESERVOIR AND THE BOLUS HISTORY WAS INCORRECT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437945 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR