BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722NAL PRDGM INS V2.2 CL EN PR

    MDR report key: 2971284 · Received November 15, 2007

    Report

    Report Number
    3004209178-2007-04732
    Event Type
    Injury
    Date Received
    November 15, 2007
    Date of Event
    November 1, 2007
    Report Date
    November 2, 2007
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    CGA
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE 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

    IT WAS STATED THAT THE CUSTOMER WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS AND THE READING WAS OVER 600 MG/DL. THE CUSTOMER CHANGED THE INFUSION SET AND ATTEMPTED TO BOLUS BUT GOT A NO DELIVERY ALARM. IT WAS STATED THAT THE INFUSION SET WAS REMOVED AND THERE WAS BLOOD ON THE CANNULA. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP PASSED THE PRIME TEST. THE NURSE STATED THAT THE CUSTOMER IS NEW TO INSULIN PUMP THERAPY AND NEEDS ADDITIONAL TRAINING. IT WAS EXPLAINED THAT THE CUSTOMER MIGHT NEED TO USE A DIFFERENT INFUSION SET. THE NURSE CALLED BACK STATING THAT THE CUSTOMER IS NOW USING A DIFFERENT SET AND THAT SET IS WORKING MUCH BETTER FOR HER. NO ADDITIONAL TRAINING REQUIRED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722NAL PRDGM INS V2.2 CL EN PR INFUSION PUMP CGA MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization