BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-723NAS PRDGM INSULIN SMOKE EN

    MDR report key: 1853776 · Received October 1, 2010

    Report

    Report Number
    3004209178-2010-82957
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    September 15, 2010
    Report Date
    September 15, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP DID NOT ALARM NO DELIVERY. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT HER BLOOD GLUCOSE WAS HIGH, THEN SHE REMOVED THE INFUSION SET FROM HER BODY AND THE CANNULA WAS BENT. RAN A FIXED PRIME TEST AND THE INSULIN EXITED. THE HIGH PRESSURE TEST WAS NOT PERFORMED BECAUSE THE TUBING CLAMP WAS NOT AVAILABLE. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-723NAS PRDGM INSULIN SMOKE EN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR