BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 4243712 · Received November 11, 2014

    Report

    Report Number
    2032227-2014-50326
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    October 14, 2014
    Report Date
    October 14, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    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. 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. (B)(4).

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP 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 THE CUSTOMER RECEIVED A NO DELIVERY ALARM. THE CUSTOMER STATED THE ALARM OCCURRED WHEN HE ATTEMPTED TO PRIME. THE CUSTOMER'S BLOOD GLUCOSE WAS 50 MG/DL. CUSTOMER HAS TREATED THEIR BLOOD GLUCOSE WITH JUICE. CUSTOMER ALSO STATED THE ALARM WAS RESOLVED BY A RESERVOIR CHANGE. THE CUSTOMER ALSO REQUESTED TO HAVE HIS INSULIN PUMP REPLACED. CUSTOMER WILL ALSO RETURN THEIR RESERVOIR FOR ANALYSIS. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726779 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326AT H8668038

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR