BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3051730 · Received April 10, 2013

    Report

    Report Number
    3004209178-2013-92507
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 28, 2013
    Report Date
    March 28, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HAVING LOW BLOOD GLUCOSE DURING NIGHT TIME. THE BLOOD GLUCOSE READING WAS 132MG/DL AT TIME OF CALL. TROUBLESHOOTING WAS PERFORMED, AND THE DRIVE SUPPORT CAP WAS LOOSE. ADVISED THE CALLER TO DISCONTINUE THE USE OF THE INSULIN PUMP AND REVERT TO BACK UP PLAN. THE REPORTS IN THE CARELINK WERE REVIEWED AND FOUND THAT THE CUSTOMER WAS GIVING HERSELF TOO MUCH INSULIN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148640 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR