BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-515LNAP PRDGM INS V2.1 PL EN

    MDR report key: 1915795 · Received November 30, 2010

    Report

    Report Number
    2032227-2010-83301
    Event Type
    Injury
    Date Received
    November 30, 2010
    Date of Event
    November 14, 2010
    Report Date
    November 15, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 REPORTED BEING HOSPITALIZED FOR DIABETES KETOACIDOSIS AND HIGH BLOOD GLUCOSE OF 650MG/DL. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT SHE CHANGES THE INFUSION SET EVERY THREE DAYS. THE CUSTOMER STATED THAT SHE HAD REALLY LOW BLOOD GLUCOSE FIRST. THE CUSTOMER'S HUSBAND HAD HER REMOVE THE INSULIN PUMP TO TAKE A BATH. THE CUSTOMER WAS RECONNECTED TO THE DEVICE, AND THEN HER GLUCOSE LEVEL STARTED TO RISE. THE CUSTOMER STATED THAT HER BLOOD GLUCOSE HAS BEEN HIGH FOR THE PAST WEEK, AND SHE TRIED TO CHANGE THE SITE FOUR TIMES TO CORRECT THE ISSUE. RAN A FIXED TEST AND THE INSULIN EXITED. PERFORMED A HIGH PRESSURE TEST AND THE INSULIN PUMP PASSED THE TEST. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-515LNAP PRDGM INS V2.1 PL EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-515LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization