BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-722NAL PRDGM INSULIN CL EN

    MDR report key: 1232106 · Received November 3, 2008

    Report

    Report Number
    2032227-2008-01896
    Event Type
    Malfunction
    Date Received
    November 3, 2008
    Date of Event
    October 22, 2008
    Report Date
    October 22, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN 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 STATED THAT THE CANNULA OF HIS INFUSION SET WAS BENT, BUT THE INSULIN PUMP DID NOT ALARM NO DELIVERY. THE CUSTOMER STATED THAT HIS BLOOD GLUCOSE LEVELS AT THE TIME OF THE COMPLAINT WERE OVER 500 MG/DL. A TUBING CLAMP WAS NOT AVAILABLE AT THE TIME OF THE PHONE CALL TO PERFORM THE HIGH PRESSURE TEST. THE CUSTOMER WAS SENT A TUBING CLAMP AND ADVISED TO CALL BACK TO PERFORM THE HIGH PRESSURE TEST. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722NAL PRDGM INSULIN CL EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-722LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR