BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4133231 · Received October 1, 2014

    Report

    Report Number
    2032227-2014-31466
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    August 31, 2014
    Report Date
    September 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    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

    THE INSULIN PUMP HAD INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARM OR NUMBER RAMPING ANOMALY WAS NOTED. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON THE DISPLAY WINDOW, CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, AND A MISSING END CAP STICKER. NO MOISTURE DAMAGE WAS NOTED ON THE MOTOR OR ELECTRONIC ASSEMBLIES DURING THE VISUAL INSPECTION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN PUMP RECEIVED A BUTTON ERROR ALARM. CUSTOMER STATED THAT THE UP AND DOWN ARROWS BUTTONS ARE NOT RESPONDING. SHE STATED THAT WHEN SHE PRESSES THE UP BUTTON TO PROGRAM A BOLUS; THE NUMBERS SCROLL UP. THE SCREEN IS FROZEN ON THE NUMBER 6 AFTER CHANGING OUT THE BATTERY. BLOOD GLUCOSE VALUE IS 364 MG/DL. CUSTOMER STATED SHE DID GET WET FROM THE RAIN FOR 30 OR 45 SECOND. SHE STATED IT WAS VERY HOT AND SHE MAY HAVE ALSO GOTTEN SWEAT ON THE INSULIN PUMP. THERE IS NOT ANY CONDENSATION SEEN ON THE SCREEN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610801 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR