BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 3150893 · Received June 6, 2013

    Report

    Report Number
    3004209178-2013-94474
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 20, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSPECTED THREE RANDOMLY SEALED RESERVOIRS. PERFORMED PRE-FILL RESERVOIR TEST PER SPECIFICATIONS. RESERVOIRS PASSED PER SPECIFICATION. NO OCCLUDED ANOMALIES WERE OBSERVED DURING ANALYSIS.

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE TRANSFER GUARD IS TOO SMALL AND DOES NOT FIT ONTO THE VIAL. THE CUSTOMER WAS UNABLE TO FILL THE RESERVOIR WITH INSULIN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251220 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326A H8236772

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR