BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 3112605 · Received May 14, 2013

    Report

    Report Number
    3004209178-2013-93478
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 19, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. 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.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT HOSPITALIZATION DUE TO DIABETIC KETOACIDOSIS. INSULIN HAD LEAKED INTO THE RESERVOIR COMPARTMENT. CUSTOMER'S BLOOD GLUCOSE READING IS 300 MG/DL. CUSTOMER HAS TREATED WITH INSULIN. INSULIN HAS LEAKED PAST THE SECOND O-RING. CUSTOMER STATED THAT THE RESERVOIR LEAKED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212202 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326A

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization