BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4123394 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-29674
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 21, 2014
    Report Date
    September 5, 2019
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    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

    THE INSULIN PUMP FUNCTIONED PROPERLY DURING REWIND, BASIC OCCLUSION, OCCLUSION, PRIME/A33, EXCESSIVE NO DELIVERY AND DISPLACEMENT TESTS. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW, CRACKED RESERVOIR TUBE LIP AND CRACKED PUMP BELT CLIP SLOT. NO CRACKED ON LCD SCREEN NOTED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW, CRACKED RESERVOIR TUBE LIP AND CRACKED PUMP BELT CLIP SLOT. NO CRACKED ON LCD SCREEN NOTED. DEVICE FUNCTION PROPERLY DURING REWIND & BASIC OCCLUSION, OCCLUSION, PRIME , THE EXCESSIVE NO DELIVERY AND DISPLACEMENT TEST.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP HAD A CRACKED AND SCRATCHED LCD SCREEN. ALSO, THE TOP OF THE DEVICE, BETWEEN THE RESERVOIR AND THE BATTERY COMPARTMENT, HAD BROKEN OFF PIECES. THE CUSTOMER'S BLOOD GLUCOSE WAS 295 MG/DL, WHICH THE CUSTOMER HAD TREATED WITH INSULIN AND THEY DECLINED TROUBLESHOOTING. THE DISCONTINUATION OF THE DEVICE WAS ADVISED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602228 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR