BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3930529 · Received July 12, 2014

    Report

    Report Number
    3004209178-2014-86719
    Event Type
    Malfunction
    Date Received
    July 12, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP RECEIVED WITH BROKEN OFF END CAP, CRACKED DISPLAY WINDOW CORNER, CRACKED BATTERY TUBE THREADS AND 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

    CUSTOMER CALLED REPORTING PHYSICAL DAMAGE TO HIS INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 319 MG/DL. HE STATED THAT THE BACK OF THE DEVICE FELL OFF. THE DEVICE WAS NOT BUMPED OR DROPPED. CUSTOMER STATED THE DEVICE WAS ALARMING NO DELIVERY AND MAKING STRANGE NOISES. THE BACK OF THE INSULIN PUMP FELL OFF WHEN CUSTOMER WAS PRIMING THE DEVICE. HE SAID IT LOOKS LIKE THE GLUE CAME OFF OF THE PISTON. THERE IS ALSO A SCRATCH ON THE DEVICE FROM A YEAR AGO. CUSTOMER WAS ADVISED THE DEVICE WILL NEED TO BE REPLACED, AND TO DISCONTINUE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408885 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR