BEUDAMED
    FDA Adverse Event Injury Summary report: N

    630G INSULIN PUMP

    MDR report key: 6177670 · Received December 15, 2016

    Report

    Report Number
    2032227-2016-50121
    Event Type
    Injury
    Date Received
    December 15, 2016
    Date of Event
    November 17, 2016
    Report Date
    November 18, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PUMP PASSED THE SELF-TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST AND DISPLACEMENT TEST. INSTALLED A WATER FILLED RESERVOIR, PRIMED PUMP, AND PROGRAMMED WITH MULTIPLE BOLUSES. OBSERVED LIQUID EXIT THE TUBING DURING THE BOLUS DELIVERIES. ALL BOLUSES DELIVERED PROPERLY AND WERE LISTED IN THE DAILY HISTORY SCREEN. NO DELIVERY ANOMALIES NOTED DURING TESTING. THE INSULIN FLOW BLOCKED ALARM FUNCTIONED PROPERLY DURING THE BASIC OCCLUSION, OCCLUSION, AND FORCE SENSOR TESTS. PUMP RECEIVED WITH SCRATCHED CASE AND PILLOWING KEYPAD OVERLAY. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL OF ISSUES WITH HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER'S BLOOD GLUCOSE LEVEL AT THE TIME OF INCIDENT WAS 265MG/DL. THE CUSTOMER'S MOST CURRENT LEVEL WAS 400MG/DL. THE CUSTOMER TREATED THE HIGHS WITH THE PUMP. TROUBLESHOOT WAS CONDUCTED. THE DEVICE FAILED HIGH PRESSURE TESTING. THE CUSTOMER WAS ADVISED THE PUMP WOULD BE REPLACED AND RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826723 630G INSULIN PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715K

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other