BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODEL NOT SPECIFIED

    MDR report key: 2791832 · Received October 15, 2012

    Report

    Report Number
    2032227-2012-07429
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    September 29, 2012
    Report Date
    September 29, 2012
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PATIENT

    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE READING AT TIME OF CALL WAS 282MG/DL. THE CALLER MENTIONED THAT THE CANNULA WAS BENT AND THE INSULIN PUMP DID NOT ALARM NO DELIVERY. TROUBLESHOOTING WAS PERFORMED, AND THE DEVICE PASSED THE HIGH PRESSURE TEST. ADVISED THE CUSTOMER THAT THE INSULIN PUMP IS FUNCTIONING AS DESIGNED. FOUND THAT THE CUSTOMER USES THE QUICK SERTER AND PINCHES AN INCH OF SKIN DURING INSERTION. INSTRUCTED THE CALLER TO CHANGE THE ENTIRE INFUSION SET AND RESERVOIR. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODEL NOT SPECIFIED INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization