BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESERVOIR 3ML

    MDR report key: 4143413 · Received September 27, 2014

    Report

    Report Number
    2032227-2014-30098
    Event Type
    Injury
    Date Received
    September 27, 2014
    Date of Event
    August 29, 2014
    Report Date
    August 29, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    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. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED BEING HOSPITALIZED FOR HIGH BLOOD GLUCOSE. DATE OF HOSPITALIZATION WAS (B)(6) 2014. BLOOD GLUCOSE AT THE TIME OF ADMISSION WAS 600 MG/DL. THE CUSTOMER STATED SHE WAS TREATED WITH A 20 UNITS INJECTION OF HOMOLOG. THE CUSTOMER STATED SHE HAD SYMPTOMS OF HIGH BLOOD GLUCOSE SUCH AS THIRST, CONFUSION, AND STOMACH PAIN. THE CUSTOMER ALSO REPORTED THE CAUSE OF HER HOSPITALIZATION WAS HER HYPERGLYCEMIA. THE CUSTOMER WAS ALSO TREATED WITH FLUIDS, POTASSIUM, AND PROTEOMICS AT THE HOSPITAL. TROUBLESHOOTING FOR THE INSULIN PUMP FOUND INSULIN WAS ABLE TO EXIT FROM THE TUBING. THE CUSTOMER ALSO STATED THERE WAS NO LEAK PRESENT. IT WAS ALSO REPORTED THE CANULA WAS SLIGHTLY OCCLUDED. THE CUSTOMER'S BLOOD GLUCOSE HAD DECLINED TO 402 MG/DL AT THE END OF THE CALL. NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603299 RESERVOIR 3ML FRN MEDTRONIC MINIMED MMT-332A

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization