BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 3854461 · Received June 6, 2014

    Report

    Report Number
    3004209178-2014-85323
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 12, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS
    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 LEAKAGE ANOMALY WAS OBSERVED DURING ANALYSIS. CHECKED O-RINGS FOR DEFECTS AND NONE WERE FOUND. RESERVOIR CONNECTED AND LOCKED IN PLACE PROPERLY.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED NO DELIVERY DURING THE MANUAL PRIME. CUSTOMER STATED SHE HAS USED THE INSULIN PUMP FOR 10-12 YEARS AND FEELS THAT EACH RESERVOIR IN THE CURRENT BATCH HAS HAD SOMETHING WRONG WITH IT. CUSTOMER HAS TRIED THE MANUAL PRIME WITH OTHER RESERVOIRS AND INFUSION SETS AND INSULIN IS STILL NOT EXITING FROM THE TUBING. CUSTOMER WILL CONTACT HER DOCTOR AND REVERT TO TREATMENT WITH MANUAL INJECTION. THE BLOOD GLUCOSE READING AT THE TIME OF THE CALL WAS 184 MG/DL. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332754 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326A H9085066

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR