BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML MMT-332A

    MDR report key: 3073703 · Received April 23, 2013

    Report

    Report Number
    3004209178-2013-92704
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 2, 2013
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSPECTED ONE OPENED AND USED RESERVOIR. 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.

    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. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MOISTURE WAS IN THE RESERVOIR COMPARTMENT. THE INSULIN PUMP HAD MOTOR ERROR AND KEPT REWINDING. CUSTOMER BECAME UPSET AND STARTED TO CRY, COULD NOT CONTINUE WITH REPORTING INCIDENT, (B)(6) (DAUGHTER-IN-LAW) HAD TAKEN OVER THE REPORTING. MOTOR ERROR ALARM EXPLAINED, ASSISTED IN CLEARING ALARM. UNABLE TO REWIND THE INSULIN PUMP. THE INSULIN PUMP KEPT REWINDING. ADVISED THAT INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174737 RESERVOIR 3ML MMT-332A RESERVOIR FRN MMT-332A

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR