BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-512LNAP PRDGM INS PL EN US LN

    MDR report key: 1211726 · Received October 23, 2008

    Report

    Report Number
    2032227-2008-01826
    Event Type
    Injury
    Date Received
    October 23, 2008
    Date of Event
    September 18, 2008
    Report Date
    October 10, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K030531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 STATED THAT SHE WAS HOSPITALIZED DUE TO HYPERGLYCEMIA. THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE WAS OVER 500 MG/DL AT THE TIME OF THE EVENT. DURING THE PHONE CALL, THE CUSTOMER STATED THAT THE INSULIN PUMP WAS MAKING A STRANGE NOISE DURING THE REWIND. THE CUSTOMER DID NOT KNOW HOW MUCH INSULIN TO TAKE TO TREAT HER DIABETES, SO HER DAUGHTER STATED SHE WAS GOING TO TAKE THE CUSTOMER TO THE HOSPITAL AGAIN. NOTHING FURTHER WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization