BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4850799 · Received June 17, 2015

    Report

    Report Number
    3004209178-2015-66106
    Event Type
    Malfunction
    Date Received
    June 17, 2015
    Date of Event
    May 29, 2015
    Report Date
    May 29, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH CORRODED KEYPAD TRACES. HOWEVER, ALL OF THE BUTTONS ARE FUNCTIONING PROPERLY AND NO BUTTON ERROR ALARM DURING TESTING. NO RAMPING NUMBERS NOTED ON THE DISPLAY. THE INSULIN PUMP HAS CRACKED BATTERY TUBE THREAD, CRACKED BELT CLIP SLOT, CRACKED CASE NEAR THE DISPLAY WINDOW CORNERS, MINOR SCRATCHES ON THE DISPLAY WINDOW, CRACKED RESERVOIR TUBE LIP, CRACKED RESERVOIR TUBE WINDOW, AND CRACKED RESERVOIR TUBE NOTED.

    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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A KEYPAD ANOMALY AND ALARMED BUTTON ERROR. THE CUSTOMER STATED THAT SHE WENT TO USE THE BOLUS WIZARD, TRIED TO USE THE UP AND DOWN ARROWS TO ADD A BOLUS, THE BUTTONS BECAME STUCK. SHE STATED THAT THE NUMBERS WENT BERSERK. THE INSULIN PUMP ALARMED BUTTON ERROR THEREAFTER. THE CUSTOMER'S BLOOD GLUCOSE WAS 216 MG/DL. THE CUSTOMER DID NOT OBSERVE ANY SIGNIFICANT EVENTS LEADING TO THE ALARM. SHE NOTED THAT SHE KEPT THE DEVICE IN HER LEATHER CASE OR IN A ZIPPERED CASE. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. THE CUSTOMER WAS ADVISED TO REPLACE THE INSULIN PUMP AND A REQUEST WAS MADE TO HAVE THE DEVICE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393057 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR