BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 4241881 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-50125
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 13, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    OTHER

    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. THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE CUSTOMER HAD HIGH BLOOD GLUCOSE. IT WAS FOUND THE CUSTOMER'S BLOOD GLUCOSE ROSE TO 483 MG/DL . IT WAS ALSO FOUND THE CUSTOMER WAS RECEIVING NO DELIVERY ALARMS. TROUBLESHOOTING FOUND THE ALARMS DID NOT OCCUR DURING A MANUAL PRIME. TROUBLESHOOTING COULD NOT DETERMINE THE CAUSE OF THE ISSUE. IT WAS FOUND CHANGING THE INFUSION SET RESOLVED THE NO DELIVERY ALARMS. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723447 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326A HG08FA3

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR