BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 4202019 · Received September 17, 2014

    Report

    Report Number
    2032227-2014-24013
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Date of Event
    August 18, 2014
    Report Date
    August 18, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    K030531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFO 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 WAS UNABLE TO PRIME DURING THE PRIME TEST DUE TO MOISTURE DAMAGE ON THE FORCE SENSOR. CORRODED MOTOR HOME SWITCH NOTED DURING VISUAL INSPECTION. THE DEVICE WAS RECEIVED WITH CRACKED CASE ON THE DISPLAY WINDOW CORNERS, MINOR SCRATCHED LCD WINDOW, CRACKED RESERVOIR TUBE, CRACKED RESERVOIR TUBE LIP, BROKEN BATTERY TUBE THREADS, AND MISSING END CAP STICKER.

    Description of Event or Problem · 1

    CUSTOMER'S DOCTOR CALLED STATING CUSTOMER'S INSULIN PUMP IS NO LONGER WORKING AND HE NEEDS A NEW ONE. CUSTOMER'S BLOOD GLUCOSE IS 120 MG/DL. HE STATED THAT INSULIN CONTINUES TO DRIP AFTER THE MOTOR STOPS DURING THE MANUAL PRIME PROCESS. TROUBLESHOOTING WAS ALREADY COMPLETED WITH ANOTHER COMPANY REP. CUSTOMER WAS ADVISED THE DEVICE NEEDS TO BE REPLACED, AND NO DISCONTINUE USE AND REVERT TO A BACK UP PLAN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577282 PARADIGM INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-512RNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR