BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 3073593 · Received April 23, 2013

    Report

    Report Number
    2032227-2013-01499
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 3, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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'S DAUGHTER CALLED TO REPORT THAT THE CUSTOMER IS SHAKING VERY BADLY, AND DOESN'T KNOW WHY. THE REPORTED BLOOD GLUCOSE READING AT THE TIME OF THE CALL WAS 167 MG/DL. THE CALLER ALSO STATED THAT THE CUSTOMER HAD NOT EATEN LUNCH YET. ADVISED THE CALLER TO EITHER TAKE THE CUSTOMER TO THE EMERGENCY ROOM OR CALL 911. THE CALLER STATED THAT SHE WILL TAKE HER IN TO GET ASSESSED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175481 INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization