BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 4123081 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-29641
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PATIENT

    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED NO DELIVERY. THE BLOOD GLUCOSE READING WAS 257 MG/DL. ADVISED THE CUSTOMER TO REMOVE THE RESERVOIR FROM THE INSULIN PUMP, DISCONNECT AND RECONNECT THE RESERVOIR AND INFUSION SET AT THE TUBING CONNECTOR AND PUSH INSULIN SLOWLY THROUGH THE TUBING. UPON TROUBLESHOOTING, IT WAS FOUND THAT INSULIN DID NOT EXIT THE TUBING. THE CUSTOMER STATED THAT INSULIN DID NOT EXIT WITH A PLUNGER PUSH AND THAT THERE WAS GREATER THAN NORMAL RESISTANCE. ADVISED REPLACEMENT OF THE INFUSION SET. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600785 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC MINIMED MMT-332A

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR UNOMEDICAL PRODUCT