BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3831225 · Received May 23, 2014

    Report

    Report Number
    3004209178-2014-84967
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 6, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    OTHER

    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

    UNABLE TO PRIME DURING THE PRIME TEST AND INSULIN PUMP ALARMED DURING THE BASIC OCCLUSION TEST DUE TO A PROTRUDED/LOOSE DRIVE SUPPORT DISK. A SCRATCHED LCD WINDOW, CRACKED BATTERY TUBE THREADS AND CRACKED RESERVOIR TUBE LIP NOTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP WAS ALARMING DURING THE PRIMING PROCESS, HAVING TO REWIND AND REPROGRAM THE INSULIN PUMP. THE CUSTOMER ALSO REPORTED THAT THE UNIT WAS SQUIRTING THE INSULIN OUT DURING THE MANUAL PRIME AND THE DEVICE WAS STUCK IN THE REWIND/DELIVERY LOOP. THE CUSTOMER STATED THAT THE INSULIN PUMP MAY BE UNDER DELIVERING BECAUSE THE NUMBERS STOP AND IT GOES TO REWIND. THE BLOOD GLUCOSE READING WAS 436 MG/DL. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308265 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR