BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RSVR MMT-332A 10PK PRDGM 3CC 14L

    MDR report key: 1032855 · Received April 22, 2008

    Report

    Report Number
    2032227-2008-00693
    Event Type
    Injury
    Date Received
    April 22, 2008
    Date of Event
    March 30, 2008
    Report Date
    April 17, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FMF
    PMA / PMN Number
    K032005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN 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 HOSPITALIZED FOR DIABETIC KETOACIDOSIS AND THE BLOOD GLUCOSE READING WAS 502 MG/DL. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP HAD THE WRONG TIME. ALL OTHER SETTINGS WERE CORRECT. DURING TROUBLESHOOTING THE CUSTOMER STATED THAT INSULIN WAS LEAKING FROM THE RESERVOIR, WHICH THE CUSTOMER BEGAN USING PRIOR TO THE HOSPITALIZATION. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSVR MMT-332A 10PK PRDGM 3CC 14L RESERVOIR FMF MEDTRONIC MINIMED MMT-332A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization