BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-512RNAP PRDGM INS PL EN US RC

    MDR report key: 1060343 · Received June 13, 2008

    Report

    Report Number
    2032227-2008-00981
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    February 27, 2008
    Report Date
    May 30, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K030531
    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 CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HYPERGLYCEMIA AND A URINARY TRACT INFECTION. THE BLOOD GLUCOSE READING WAS NOT REPORTED. THE CUSTOMER'S NURSE STATED THAT THE INSULIN PUMP ALARM MOTOR ERROR AND THAT THE CUSTOMER HAS HAD TROUBLE CONTROLLING HER BLOOD GLUCOSE LEVELS. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP PASSED THE DISPLACEMENT TEST. A REPLACEMENT INSULIN PUMP WAS SENT TO THE CUSTOMER DUE TO THE MOTOR ERROR ALARM. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-512RNAP PRDGM INS PL EN US RC INFUSION PUMP LZG MEDTRONIC MINIMED MMT-512RNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization