BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 4212473 · Received October 25, 2014

    Report

    Report Number
    2032227-2014-43526
    Event Type
    Injury
    Date Received
    October 25, 2014
    Date of Event
    February 14, 2014
    Report Date
    September 26, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE REFERENCE MEDWATCH 2032227-2014-43374. 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. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE WENT TO THE EMERGENCY ROOM ON (B)(6) 2014 FOR A BLOOD GLUCOSE LEVEL OF 20 MG/DL. THE CUSTOMER WAS ADMITTED TO SUBURBAN HOSPITAL. THE CUSTOMER EXPERIENCED A VEHICULAR ACCIDENT PRIOR TO THE HOSPITALIZATION. THE CUSTOMER STATES THAT THE LOW BLOOD GLUCOSE LEVELS MAY HAVE BEEN CAUSED BY NOT EATING LUNCH ON TIME THAT DAY. THE INSULIN PUMP WAS UNAVAILABLE AT THE TIME OF THE CALL. THE CUSTOMER STATED THAT SHE TOOK TRAZADONE AND TROLIA INJECTIONS AT THE TIME OF THE EVENT. THE INSULIN PUMP WAS NOT EXPOSED TO ANY STRONG MAGNETIC FIELDS. NO FURTHER INFO WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680688 INSULIN INFUSION PUMP OYC OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization