BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-512LNAL PRDGM INS CL EN US LN

    MDR report key: 1031183 · Received April 17, 2008

    Report

    Report Number
    2032227-2008-00658
    Event Type
    Injury
    Date Received
    April 17, 2008
    Date of Event
    April 3, 2008
    Report Date
    April 3, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K030531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SHE WAS TREATED IN THE EMERGENCY ROOM FOR A LOW BLOOD GLUCOSE READING OF 58 MG/DL. THE CUSTOMER STATED THAT SHE HAD BEEN EXPERIENCING HIGH AND LOW BLOOD GLUCOSE LEVELS FOR THE PAST THREE WEEKS. THE CUSTOMER ALSO HAD A URINARY TRACT INFECTION, BUT SHE DIDN'T KNOW IF THAT HAD ANYTHING TO DO WITH THE BLOOD GLUCOSE LEVELS. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY EXCEPT FOR THE TIME, WHICH WAS OFF BY AN HOUR. THE INSULIN PUMP ALSO PASSED THE HIGH PRESSURE TEST. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-512LNAL PRDGM INS CL EN US LN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-512LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention