BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 4885317 · Received July 1, 2015

    Report

    Report Number
    3004209178-2015-70502
    Event Type
    Injury
    Date Received
    July 1, 2015
    Date of Event
    March 9, 2015
    Report Date
    June 12, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE RESERVOIR SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD REPLACED THE RESERVOIR AND CATHETER THE DAY BEFORE. THE PUMP TRIGGERED A NO DELIVERY ALARM THE FOLLOWING NIGHT. CUSTOMER WAS HOSPITALIZED WITH HIGH BLOOD GLUCOSE OF 600 MG/DL. DURING THE HOSPITALIZATION, THE NURSES REPLACED THE CATHETER AND RESERVOIR AND THE SAME ISSUE OCCURRED AGAIN. THE INFUSION SET WAS CHANGED AND THE ISSUE WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428628 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326A HG0722Y

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization