BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 4090391 · Received September 15, 2014

    Report

    Report Number
    2032227-2014-23082
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    August 16, 2014
    Report Date
    August 16, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    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

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING, IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT AIR BUBBLES IN THE RESERVOIR. BLOOD GLUCOSE READING WAS 89 MG/DL AT NIGHT. THE BLOOD GLUCOSE READING WENT UP TO 329 MG/DL IN THE MORNING. THE SIZE OF THE AIR BUBBLES WERE SMALL AND THEY OCCURRED AT THE TOP AND BOTTOM OF THE RESERVOIR. TROUBLESHOOTING WAS PERFORMED. THE CANNULA ON THE INFUSION SET WAS BENT. AIR BUBBLES PERSISTED AFTER THE INFUSION SET WAS CHANGED. ADVISED THAT THE INFUSION SET WILL BE REPLACED. THE RESERVOIR AND INFUSION SETS WILL BE RETURNED FOR ANALYSIS. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568581 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC MINIMED MMT-332A

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR