BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 3945080 · Received July 18, 2014

    Report

    Report Number
    3004209178-2014-87758
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 15, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    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.

    Additional Manufacturer Narrative · 1

    INSPECTED ONE OPENED AND USED RESERVOIR. INSPECTED RESERVOIR, SNAP-CAP AND SEPTUM FOR ANOMALIES. NONE WERE FOUND. PERFORMED MANUAL PRIME AND HIGH PRESSURE TEST PER SPECIFICATIONS. RAN PRIMING IN INSULIN PUMP. RESERVOIR PASSED PER SPECIFICATION. NO OCCLUSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED NO DELIVERY. THE BLOOD GLUCOSE READING WAS UNKNOWN. THE CUSTOMER CHANGED THE INFUSION SET, THEN TRIED TO PRIME THE TUBING AGAIN AND RECEIVED A MOTOR ERROR ALARM. THE ISSUE WAS RESOLVED BY A COMPLETE SET CHANGE. THE CUSTOMER REQUESTED TO RETURN THE RESERVOIR FOR ANALYSIS. CALLER WAS NOT ABLE TO TROUBLESHOOT AT THE TIME OF THE CALL; RETURNING THE PRODUCT BASED ON THE CUSTOMER'S REQUEST. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421863 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326A HG009J8

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR