BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MTT-522NAL PRDGM INS V2.2 CL EN

    MDR report key: 1231863 · Received November 12, 2008

    Report

    Report Number
    3004209178-2008-00962
    Event Type
    Injury
    Date Received
    November 12, 2008
    Date of Event
    November 2, 2008
    Report Date
    November 2, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 COMPLAINED OF THE INSULIN PUMP ALARMING NO DELIVERY. DURING THE PHONE CALL, THE CUSTOMER REPORTED THAT SHE WAS HOSPITALIZED DUE TO HYPERGLYCEMIA AND DIABETIC KETOACIDOSIS. THE REPORTED BLOOD GLUCOSE READING WAS 146 MG/DL. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE PRIME TEST PASSED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MTT-522NAL PRDGM INS V2.2 CL EN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-522NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization