BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 4103449 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-26297
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 21, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    EVALUATED ONE OPENED/USED RESERVOIR. INSPECTED RESERVOIR, SNAP-CAP, AND SEPTUM FOR ANOMALIES. NONE WERE FOUND. RAN THE OCCLUSION AS FOLLOWS: RESERVOIR FILLED WITH DILUENT, AND CONNECTED TO A NEW INFUSION SET. INSTALLED THE RESERVOIR AND CONNECTOR INTO AN INSULIN PUMP. PERFORMED THE INFUSION SET TEST. INSTALLED THE RESERVOIR AND CONNECTOR INTO AN INSULIN PUMP AND PERFORMED CATHETER TIP TEST. CONCLUSION: THE RESERVOIR WAS NOT OCCLUDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING NO DELIVERY ALARMS DURING BOLUS AND PRIME. CUSTOMER ALSO MENTIONED BEING STUCK IN THE PRIME LOOP IN THE PAST. CUSTOMER'S MOST RECENT BLOOD GLUCOSE READING WAS 120 MG/DL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584662 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC MINIMED MMT-332A H8146167

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR