BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2230895 · Received July 20, 2011

    Report

    Report Number
    3004209178-2011-82239
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 8, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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 INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED EXPERIENCING HIGH BLOOD GLUCOSE FOR THE PAST WEEK, AND SHE HAS CHANGED THE INFUSION SET SEVERAL TIMES OVER THE PAST 36 HOURS. TROUBLESHOOTING WAS PERFORMED. THE TIME, DATE, AND PROGRAMMING WERE CORRECT. RAN A FIXED PRIME TEST AND FOUND THAT THE CANNULA WAS BENT. PERFORMED A HIGH PRESSURE TEST MANY TIMES AND THE INSULIN PUMP FAILED THE TEST. ADVISED THE CUSTOMER THAT SHE NEEDS A REPLACEMENT OF THE INSULIN PUP AND TO REVERT TO BACK UP PLAN. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-522NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 QUICK-SET, 23, PARADIGM, 6MM CATHETER| UNOMEDICAL INFUSION SET, MMT-399