BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4090308 · Received September 15, 2014

    Report

    Report Number
    2032227-2014-23205
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    August 16, 2014
    Report Date
    August 16, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP HAD MINOR SCRATCHED LCD WINDOW, CRACKED CASE NEAR THE DISPLAY WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP, DETACHED END CAP. UNABLE TO PERFORM THE DISPLACEMENT TEST DUE TO DETACHED END CAP ANOMALY. THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE AND PASSED THE MOTOR TEST.

    Description of Event or Problem · 1

    CUSTOMER REPORTED HE DROPPED HIS INSULIN PUMP ON THE FLOOR AND THE BOTTOM PLATE FELL OFF. THE MOTOR FELL OUT AND THE DEVICE IS INOPERABLE. CUSTOMER'S BLOOD GLUCOSE IS 109 MG/DL. CUSTOMER WAS ADVISED THE DEVICE NEEDS TO BE REPLACED, AND TO DISCONTINUE USE AND REVERT TO A BACK UP PLAN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568445 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR