BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4862478 · Received June 23, 2015

    Report

    Report Number
    2032227-2015-19977
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Date of Event
    June 5, 2015
    Report Date
    June 4, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO BUTTON ERROR ALARM DURING TESTING. HOWEVER, THE INSULIN PUMP HAD INTERMITTENT BUTTONS RESPONSE DUE TO CORRODED KEYPAD TRACES. NO UNEXPECTED NUMBERS RAMPING/SCROLLING DURING TESTING. NO MOISTURE DAMAGE ON ELECTRONIC ASSEMBLY DURING VISUAL INSPECTION. THE INSULIN PUMP HAD MINOR SCRATCHES ON LCD WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNER, CRACKED BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE LIP AND MISSING END CAP STICKER.

    Additional Manufacturer Narrative · 1

    THE DATE OF EVENT WAS INCORRECT IN THE INITIAL REPORT. THE CORRECT DATE OF EVENT HAS BEEN PROVIDED WITH THIS REPORT.

    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT HE HAD A BUTTON ERROR ALARM ON THE INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE WAS 108 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER STATED THAT IT WAS PROBABLY CAUSED BY SWEAT. CUSTOMER STATED THAT IT HAD CHANGED HIS BASAL AND WAS RUNNING THEM ALL DOWN TO ZERO. CUSTOMER WAS ADVISED THAT THE PUMP WILL NEED TO BE REPLACED. CUSTOMER WAS ALSO ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP PLAN. CUSTOMER AGREED TO RETURN THE PUMP. CUSTOMER MENTIONED THAT HE DOES NOT WEAR THE BELT CLIP BECAUSE IT IS INCONVENIENT WHEN SKATE BOARDING. CUSTOMER WAS RECOMMENDED TO LOCK THE KEYPAD TO AVOID RANDOM BUTTON PRESSES WHILE IT IS IN HIS POCKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406655 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR