BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 3973995 · Received August 1, 2014

    Report

    Report Number
    3004209178-2014-88998
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THE INSULIN PUMP ALARMED DURING THE PRIME PROCESS. BLOOD GLUCOSE READING AT THE TIME WAS 159 MG/DL. CUSTOMER MENTIONED THAT TWO SETS FROM THE SAME BOX DID NOT FUNCTION PROPERLY. THIS ISSUE WAS RESOLVED BY A COMPLETE SET CHANGE DONE BY THE CUSTOMER PRIOR TO CALLING. TROUBLESHOOTING COULD NOT BE PERFORMED AT THIS TIME. ADVISED THE CUSTOMER THAT THE RESERVOIR WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451211 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A HG034KZ

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR