BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 4103596 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-26670
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 16, 2014
    Report Date
    August 22, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSPECTED RESERVOIR, SNAP-CAP AND SEPTUM FOR ANOMALIES NONE WERE FOUND. PERFORMED OCCLUSION TEST PER SPECIFICATIONS, RESERVOIR FILLED AND CONNECTED TO NEW INFUSION SET. INSTALLED RESERVOIR AND CONNECTOR INTO INSULIN PUMP AND PERFORMED INFUSION SET. INSTALLED RESERVOIR AND CONNECTOR TO INSULIN PUMP AND PERFORMED CATHETER TIP. RESERVOIR NOT OCCLUDED.

    Additional Manufacturer Narrative · 1

    THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4) SITE, PER VARIANCE 5. 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

    IT WAS REPORTED CUSTOMER WAS TRYING TO FILL THE RESERVOIR AND THE INSULIN WOULD NOT FLOW IN. CUSTOMER'S MOTHER STATED THAT CUSTOMER USED THE PLUNGER AND WAS ABLE TO PUT AIR IN BUT UNABLE TO PUT THE INSULIN. CUSTOMER'S MOTHER WAS ADVISED TO USE A NEW RESERVOIR. CUSTOMER BLOOD GLUCOSE WAS NOT CAPTURED. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581705 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC MINIMED MMT-332A HG050RU

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR