BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 4123653 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-29794
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 29, 2014
    Report Date
    August 29, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED NO DELIVERY DURING THE PRIMING PROCESS. THE CUSTOMER STATED THAT THEY HAD RUN OUT OF SUPPLIES AND HAD USED A PREFILLED RESERVOIR. THE CUSTOMER'S BLOOD GLUCOSE WAS 91 MG/DL. SINCE THE CUSTOMER DID NOT HAVE SUPPLIES, ONLY PARTIAL TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP ALARMED NO DELIVERY, AGAIN, DURING MANUAL PRIMING. THE CUSTOMER HAD ALREADY REVERTED TO REVERTED TO A BACKUP PLAN. THE CUSTOMER THOUGHT THAT THE BUTTONS WERE NOT WORKING, BUT THEY STATED THAT THEY HAD A PINCHED NERVE IN THEIR HAND, WHICH MADE IT DIFFICULT FOR THEM TO OPERATE THE INSULIN PUMP. THE CUSTOMER TRIED THEIR OTHER HAND, AND THE BUTTONS WERE ACTUALLY OPERATING PROPERLY. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602320 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC MINIMED MMT-326A

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR