BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3801211 · Received May 8, 2014

    Report

    Report Number
    3004209178-2014-84453
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    August 9, 2013
    Report Date
    May 1, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS RECEIVED WITH OPERATING CURRENTS WITHIN SPECIFICATIONS. THE DEVICE PASSED THE ERROR AND DISPLACEMENT TESTS. HOWEVER, THE UNIT WAS UNABLE TO PRIME DURING THE PRIME TEST AS A RESULT OF A LOOSE/PROTRUDED DRIVE SUPPORT DISK. FURTHER TESTING COULD NOT BE PERFORMED DUE TO THE PRIME ANOMALY. THE DEVICE WAS RECEIVED WITH CRACKED CASE AT THE DISPLAY WINDOW CORNERS, DISPLAY WINDOW AND BATTERY TUBE THREADS, SCRATCHED SCREEN, DEBRIS UNDER THE DISPLAY WINDOW, AND TRACES OF MOISTURE AT THE LCD ASSEMBLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CUSTOMER LOST HIS INSULIN PUMP WHILE STAYING IN A CAMP. THE CALLER STATED THAT HE WENT TO SWIM, TOOK THE DEVICE OFF, AND LOST IT. IT WAS STATED THAT HE NOTICED DID NOT HAVE THE DEVICE WHEN HE WENT TO BOLUS FOR A SNACK. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS TREATED WITH MANUAL INJECTIONS SINCE THEN. THE CALLER ALSO MENTIONED THAT THE CUSTOMER DROPPED THE DEVICE IN THE TOILET AND EVEN SHOWERED WITH THE DEVICE ON, AND EACH TIME SHE BLOW DRIED IT TO GET IT TO WORK AGAIN. DAYS LATER, THE GRANDMOTHER CALLED TO REPORT THAT THE INSULIN PUMP WAS FOUND, BUT IT WAS NOT FUNCTIONING. ADVISED THE CALLER TO DISCONTINUE THE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279024 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR