BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-715NAB PRDGM INS V2.1 BL EN

    MDR report key: 1092064 · Received July 31, 2008

    Report

    Report Number
    3004209178-2008-00572
    Event Type
    Injury
    Date Received
    July 31, 2008
    Date of Event
    July 20, 2008
    Report Date
    July 20, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS. THE REPORTED BLOOD GLUCOSE READING WAS 500 MG/DL. TROUBLESHOOTING WAS PERFORMED AND THE PROGRAMMING ON THE INSULIN PUMP WAS CORRECT. THE INSULIN PUMP PASSED THE PRIME TEST. THE HIGH PRESSURE TEST COULD NOT BE PERFORMED, BECAUSE A TUBING CLAMP WAS NOT AVAILABLE AT THE TIME OF THE PHONE CALL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-715NAB PRDGM INS V2.1 BL EN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-715NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization