BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4182820 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-38745
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 19, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH ALL OF THE BUTTONS FUNCTIONING PROPERLY, HOWEVER CORRODED KEYPAD TRACES WERE NOTED. THE INSULIN PUMP HAS CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, MINOR SCRATCHES ON DISPLAY WINDOW, MISSING END CAP STICKER AND CRACKED CASE NEAR DISPLAY WINDOW CORNERS NOTED DURING VISUAL INSPECTION.

    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE BUTTONS ON THE INSULIN PUMP ARE NOT RESPONDING. CUSTOMER GOT STUCK INTO THE PRIME SEQUENCE; CUSTOMER WAS TRYING TO DELIVER AN INSULIN BOLUS AND IS UNABLE TO TREAT. CUSTOMER STATED THAT HE REMOVED THE BATTERY AND PUT IT BACK IN AND ISSUE PERSISTS. NO BUTTON ERROR ALARMS OCCURRED. BLOOD GLUCOSE VALUE IS 235 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661922 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR