BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4103508 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-26483
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 21, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    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

    FAILURE ANALYSIS REVEALED THE INSULIN PUMP WAS RECEIVED WITH CURRENTS IN SPECIFICATION. NO UNEXPECTED LOW BATTERY ALARM. THE DEVICE PASSED THE REWIND, BASIC OCCLUSION, OCCLUSION, PRIME, EXCESSIVE NO DELIVERY ALARM AND DISPLACEMENT TEST. THE UNIT PASSED THE SELF TEST AND THE ERROR ALARM TEST. NO ERROR ALARM NOTED. NO UNEXPECTED EXCESSIVE NO DELIVERY ALARM NOTED. MINOR SCRATCHED LCD WINDOW, CRACKED CASE NEAR THE DISPLAY WINDOW CORNERS, CRACKED BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    CUSTOMER REPORTED HAVING BLOOD GLUCOSE LEVELS IN THE RANGE OF 300 TO 600 MG/DL FOR SEVERAL DAYS BEFORE THE CALL. CUSTOMER REPORTED FEELING LIKE THE INSULIN PUMP WAS NOT DELIVERING INSULIN. CUSTOMER STATED THAT THE INSULIN PUMP'S BATTERY HAD TO BE CHANGED THREE TIMES WITHIN ONE MONTH, AND LOST ALL SETTINGS EACH TIME. CUSTOMER REPORTED RECEIVING MULTIPLE ERROR ALARMS BLOOD GLUCOSE LEVEL WAS 305 MG/DL AT THE TIME OF THE CALL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583696 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR