BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4062069 · Received September 4, 2014

    Report

    Report Number
    2032227-2014-16306
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Date of Event
    August 5, 2014
    Report Date
    August 5, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO UNEXPECTED EXCESSIVE NO DELIVERY ALARMS WERE NOTED. THE INSULIN PUMP PASSED THE DISPLACEMENT, PRIME AND EXCESSIVE NO DELIVERY ALARM TESTS. THE INSULIN PUMP HAD MINOR SCRATCHES ON THE DISPLAY WINDOW, CRACKED RESERVOIR TUBE LIP, SCRATCHED RESERVOIR TUBE WINDOW AND CRACKED BATTERY TUBE THREADS.

    Additional Manufacturer Narrative · 1

    THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4). CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT EVERY TIME HE INSERTS THE INFUSION SET ON HIS LEFT SIDE THE INSULIN PUMP ALARMS "NO DELIVERY." CUSTOMER STATED HE HAS USED THE BACK OF HIS THIGH AND THE DEVICE STILL ALARM "NO DELIVERY." CUSTOMER STATES THE DEVICE ONLY ALARMS NO DELIVERY DURING BOLUS DELIVERY. CUSTOMER DECLINED TROUBLESHOOTING AND REQUESTED A NEW PUMP. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542923 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR