BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 1981370 · Received February 2, 2011

    Report

    Report Number
    3004209178-2011-80314
    Event Type
    Malfunction
    Date Received
    February 2, 2011
    Date of Event
    January 25, 2011
    Report Date
    January 25, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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 OF 250MG/DL. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT SHE CHANGES THE INFUSION SET EVERY THREE TO FIVE DAYS. ADVISED THE CUSTOMER TO CHANGE THE INFUSION SET EVERY TWO DAYS. RAN A FIXED PRIME TEST AND THE CUSTOMER STATED THAT INSULIN WAS LEAKING AT THE P-CAP OF THE RESERVOIR. THE CUSTOMER STATED THAT PROBABLY THE DEVICE CRACKED WHEN SHE DROPPED IT. INSTRUCTED THE CUSTOMER TO DISCONTINUE USE OF THE INSULIN PUMP 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-722NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR