BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 4223334 · Received November 4, 2014

    Report

    Report Number
    2032227-2014-46778
    Event Type
    Injury
    Date Received
    November 4, 2014
    Date of Event
    October 5, 2014
    Report Date
    October 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVELS OF 451 MG/DL. THE CUSTOMER TREATED WITH MANUAL INSULIN INJECTIONS. TROUBLESHOOTING WAS DONE. TROUBLESHOOTING WAS NOT COMPLETED BECAUSE THE CUSTOMER DID NOT HAVE TUBING CLAMPS FOR THE INSULIN PUMP. THE TUBING CLAMPS FOR THE INSULIN PUMP WOULD BE SHIPPED TO THE CUSTOMER. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708331 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326A HG01LWJ

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR