BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4252187 · Received November 14, 2014

    Report

    Report Number
    2032227-2014-52867
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    October 18, 2014
    Report Date
    October 18, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING, IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS. HOWEVER, THE INSULIN PUMP HAD MINOR SCRATCHES ON THE DISPLAY WINDOW, CRACKED CASE NEAR THE DISPLAY WINDOW CORNERS, CRACKED BATTERY TUBE THREADS AND A CRACKED RESERVOIR TUBE LIP.

    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

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED MOTOR ERROR DURING BOLUS. TROUBLESHOOTING WAS DONE. CUSTOMER'S BLOOD GLUCOSE WAS 351 MG/DL. IT WAS FOUND THAT CUSTOMER USES THE SENSOR FEATURE ON THE INSULIN PUMP. ADVISED THE CUSTOMER THE CAUSE OF THE ALARM WAS DUE TO VIEWING THE SENSOR GLUCOSE GRAPH WHILE THE INSULIN PUMP IS DELIVERING BOLUS. ADVISED THE CUSTOMER TO COMPLETE THE BOLUS DELIVERY BEFORE SENSOR GLUCOSE GRAPH. 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
    738422 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR