BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1062708 · Received June 16, 2008

    Report

    Report Number
    2032227-2008-00996
    Event Type
    Injury
    Date Received
    June 16, 2008
    Date of Event
    May 12, 2008
    Report Date
    June 2, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SHE WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS THREE WEEKS AGO. THE CUSTOMER ALSO STATED THAT THE BATTERIES ARE ONLY LASTING THREE DAYS ON THE INSULIN PUMP. THE CUSTOMER STATED THAT SHE HAS TRIED USING MANY DIFFERENT BATTERIES, BUT SHE IS GETTING SAME RESULTS. THE CUSTOMER ASKED TO HAVE THE INSULIN PUMP REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522NAL PRDGM INS V2.2 CL EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-522NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization