BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESERVOIR 3ML

    MDR report key: 3211975 · Received July 8, 2013

    Report

    Report Number
    3004209178-2013-95486
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 18, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    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. 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.PLEASE SEE MEDWATCH REPORT # 3004209178-2013-95487.

    Additional Manufacturer Narrative · 1

    INSPECTED THREE OPENED AND USED RESERVOIRS. PERFORMED MANUAL PRIME AND HIGH PRESSURE TEST PER SPECIFICATIONS. RAN PRIMING IN INSULIN PUMP. RESERVOIRS PASSED PER INSPECTION. NO OCCLUDED ANOMALIES WERE OBSERVED DURING ANALYSIS. RESERVOIRS CONNECTED AND LOCKED IN PLACE PROPERLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE, AND THE CALL BECAME DISCONNECTED. INITIALLY, THE CUSTOMER REPORTED HAVING HIGH BLOOD GLUCOSE OF 449MG/DL, AND HIS BLOOD GLUCOSE WAS TREATED WITH MANUAL INJECTIONS. TROUBLESHOOTING WAS PERFORMED, AND THE CALLER STATED THAT THE INSULIN PUMP ALARMED NO DELIVERY DURING MANUAL PRIME. ADVISED TO CHECK THE RESERVOIR AND TUBING CONNECTION. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311345 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A H8334823

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization