BEUDAMED
    FDA Adverse Event Injury Summary report: N

    630G INSULIN PUMP

    MDR report key: 6174223 · Received December 14, 2016

    Report

    Report Number
    2032227-2016-49921
    Event Type
    Injury
    Date Received
    December 14, 2016
    Date of Event
    December 8, 2016
    Report Date
    January 17, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    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 AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PUMP PASSED THE FUNCTIONAL TESTS, INCLUDING THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND, PRIME/SEATING, BASIC OCCLUSION, OCCLUSION, FORCE SENSOR AND DISPLACEMENT TESTS. THE PUMP WAS PROGRAMMED WITH MULTIPLE BOLUSES AND WAS MONITORED. ALL BOLUSES DELIVERED PROPERLY AND WERE LISTED IN THE DAILY HISTORY SCREEN. THEN, THE PUMP WAS PROGRAMMED WITH MULTIPLE BASAL PROFILES AND WAS MONITORED. ALL BASAL PROFILES DELIVERED THEIR INDICATED AMOUNTS AND WERE VERIFIED IN THE SUMMARY SCREEN. NO DELIVERY ANOMALY, BOLUS ANOMALY OR BASAL ANOMALY WAS NOTED DURING TESTING. THE PUMP ALSO COMMUNICATED PROPERLY WITH THE GLUCOSE SENSOR SIMULATOR AND THE GUARDIAN LINK. THE METER BG NOW ALARM FUNCTIONED PROPERLY. NO SENSOR ANOMALY OR CALIBRATION ANOMALY WAS NOTED. THE PUMP HAD MINOR SCRATCHES, A SCRATCHED CASE AND A PILLOWING KEYPAD OVERLAY.

    Additional Manufacturer Narrative · 1

    THE PUMP PASSED THE DELIVERY VOLUME ACCURACY TEST.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED VIA PHONE CALL INDICATING THAT THEY WERE HOSPITALIZED ON (B)(6) 2016 WITH A BLOOD GLUCOSE LEVEL OF 37 MG/DL. THE CUSTOMER HAD AN INFECTION IN BLOOD, INFECTION IN THE LEG AND A URINARY TRACT INFECTION AND FELT NAUSEOUS. THE CUSTOMER WAS TREATED FOR THEIR BLOOD GLUCOSE WITH GLUCOSE TABLETS AND IV. THE CUSTOMER'S BLOOD GLUCOSE AT THE TIME OF THE CALL WAS 446 MG/DL. THE CUSTOMER STATED THAT THEY HAD ISSUES WITH THEIR SENSOR. THE CUSTOMER WAS EDUCATED ON THE PROPER SITE AND INSERTION TECHNIQUE OF THE SENSOR TO AVOID ANY ISSUES IN THE FUTURE. THE CUSTOMER RETURNED THEIR INSULIN PUMP BACK FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823890 630G INSULIN PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715K

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other