BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-515NAB PRDGM INS V2.1 BL EN

    MDR report key: 2954040 · Received September 10, 2007

    Report

    Report Number
    3004209178-2007-04724
    Event Type
    Injury
    Date Received
    September 10, 2007
    Date of Event
    August 28, 2007
    Report Date
    August 28, 2007
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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

    IT WAS STATED THAT THE CUSTOMER WAS HOSPITALIZATION FOR HIGH BLOOD GLUCOSE. PRIOR TO THE HOSPITALIZATION, THE CUSTOMER WOKE UP VOMITING. THE REPORTED BLOOD GLUCOSE READING WAS 300 MG/DL DURING THE CALL. IT WAS STATED THAT THE RESERVOIR WAS EMPTY WHEN THEY ARRIVED AT THE HOSPITAL. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP PASSED THE REQUIRED TESTS. THE HIGH PRESSURE TEST WAS NOT PERFORMED AS THE INSULIN PUMP DID ALARM NO DELIVERY WHILE WEARING THE INSULIN PUMP AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-515NAB PRDGM INS V2.1 BL EN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-515NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization