BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4241459 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-48602
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    July 30, 2014
    Report Date
    October 15, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP RECEIVED WITH CRACKED CASE ON DISPLAY WINDOW CORNERS, MINOR SCRATCHED LCD WINDOW, CRACKED RESERVOIR TUBE, CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, AND MISSING END CAP STICKER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE INSULIN PUMP HAD VARIOUS CRACKS ON IT. CUSTOMER'S BLOOD GLUCOSE WAS 169 MG/DL. CUSTOMER WAS UNAWARE HOW DAMAGE OCCURRED. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721875 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522RNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR