BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4181315 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-39632
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    MOTOR ERROR ALARM DURING REWIND DUE TO CORRODED MOTOR HOME SWITCH. UNABLE TO PERFORM BASIC OCCLUSION, OCCLUSION, PRIME/A33, THE EXCESSIVE NO DELIVERY AND DISPLACEMENT TEST DUE TO CONSTANT MOTOR ERROR ALARM. MOISTURE DAMAGE WAS FOUND ON ELECTRONIC ASSEMBLY. PUMP WAS RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS AND CRACKED PUMP BELT CLIP SLOT. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED FALLING INTO THE POOL WITH HER INSULIN PUMP. THE CUSTOMER STATED THERE WAS NOW MOISTURE EXPOSURE TO THE INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE WAS 340 MG/DL. SHE STATED SHE HAD TREATED HER BLOOD GLUCOSE WITH A MANUAL INJECTION. THE CUSTOMER ALSO REPORTED THERE WAS MORE FREQUENT MOTOR ERROR ALARMS AND BATTERY ERROR ALARMS SINCE EXPOSING HER INSULIN PUMP TO MOISTURE. THE CUSTOMER WAS ADVISED TO DISCONNECT FROM THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661166 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR