BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    630G INSULIN PUMP 630G BLACK MG

    MDR report key: 6086817 · Received November 8, 2016

    Report

    Report Number
    2032227-2016-40556
    Event Type
    Malfunction
    Date Received
    November 8, 2016
    Date of Event
    October 17, 2016
    Report Date
    November 11, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED DISPLACEMENT TEST, REWIND TEST, PRIME SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, OCCLUSION TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT AND SELF-TEST. NO UNEXPECTED STUCK BUTTON ALARMS, DISPLAY TYPE ANOMALIES OR BLANK DISPLAY ANOMALIES NOTED DURING TESTING. ALL OF THE BUTTONS FUNCTIONED PROPERLY; NO DAMAGE WAS FOUND ON THE KEYPAD TRACES AND THE CONNECTOR ON THE PRINTED CIRCUIT BOARD WAS NOT UNLOCKED DURING VISUAL INSPECTION. THE INSULIN PUMP HAD SCRATCHED CASING, MINOR SCRATCHES ON THE LCD WINDOW AND PILLOWING KEYPAD OVERLAY.

    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED VIA PHONE CALL THAT THE DEVICE ALARMED STUCK BUTTON ALARM. CUSTOMER'S BLOOD GLUCOSE WAS 190 MG/DL. DEVICE WAS TURNED OFF. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACK-UP PLAN PER HEALTH CARE PROFESSIONALS' INSTRUCTIONS. CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WILL BE REPLACED. CUSTOMER AGREED TO RETURN THE DEVICE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739005 630G INSULIN PUMP 630G BLACK MG INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715K

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR