BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4860584 · Received June 22, 2015

    Report

    Report Number
    3004209178-2015-67639
    Event Type
    Malfunction
    Date Received
    June 22, 2015
    Date of Event
    May 30, 2015
    Report Date
    June 3, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    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 WAS RECEIVED WITH CURRENTS ARE WITHIN SPECIFICATION. NO UNEXPECTED OFF NO POWER WITHOUT LOW BATTERY OR BATTERY OUT LIMIT. THE INSULIN PUMP WAS MONITOR AND NO AUDIO BEEP ANOMALY NOTED DURING OUR TESTING. THE INSULIN PUMP WAS PROGRAM WITH MULTIPLE BOLUSES; ALL OF THE BOLUSES WERE DELIVERED PROPERLY AND WERE LISTED IN THE BOLUS HISTORY SCREEN. THE INSULIN PUMP WAS THEN PROGRAM AND MONITORED BASAL PROFILES, ALL OF THE BASAL PROFILES DELIVERED PROPERLY. NO HISTORY ANOMALY OR BLACK SCREEN NOTED DURING OUR TESTING. THE INSULIN PUMP HAS MINOR SCRATCHED LCD WINDOW AND CRACKED CASE NEAR THE DISPLAY WINDOW CORNERS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A BLACK SCREEN. SHE CHANGED THE INSULIN PUMP'S BATTERY AND IT STARTED TO WORK BUT THE NEXT DAY THE BATTERY WAS EMPTY. THE INSULIN PUMP HAD A BLACK SCREEN AGAIN. IN THE ALERT HISTORY BATTERY OUT LIMIT, THRESHOLD SUSPEND, LOW BATTERY, LOST SENSOR, AND LOW RESERVOIR ALERTS WERE FOUND. SHE DID NOT RECEIVE A LOW BATTERY ALERT PRIOR TO THE OFF NO POWER ALERT. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 290 MG/DL. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402669 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR