BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4213526 · Received October 25, 2014

    Report

    Report Number
    2032227-2014-43490
    Event Type
    Malfunction
    Date Received
    October 25, 2014
    Date of Event
    September 26, 2014
    Report Date
    September 26, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    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. THE INSULIN PUMP HAS CRACKED BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE LIP AND NO DAMAGE NOTED ON ORIGINAL BATTERY CAP.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE INSULIN PUMP ALREADY FAILED BATTERY TEST AND IT KEPT TURNING OFF. CUSTOMER'S BLOOD GLUCOSE WAS 118 MG/DL. ALARM AND POSSIBLE CAUSES WERE EXPLAINED. TROUBLESHOOTING FOR BLANK DISPLAY WAS PERFORMED. THE DEVICE ALSO HAD A CRACK IN THE BATTERY COMPARTMENT AREA STATED THE BATTERY CAP TREAD WAS CRACKED. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. NO FURTHER INFO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680444 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-523LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR