BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP MMT-751NAL

    MDR report key: 7011960 · Received November 8, 2017

    Report

    Report Number
    2032227-2017-64758
    Event Type
    Malfunction
    Date Received
    November 8, 2017
    Date of Event
    October 30, 2017
    Report Date
    March 15, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    00643169503694
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT RECEIVED WITH CURRENTS IN SPEC. NO BLANK DISPLAY. LCD BOARD OK. UNIT HAD MINOR SCRATCHED LCD WINDOW, CRACKED CASE NEAR DISPLAY WINDOW CORNERS, CRACKED BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE LIP AND CRACKED LCD WINDOW.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 BLANK DISPLAY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 169 MG/DL. ASSISTED CUSTOMER WITH TROUBLESHOOT FOR BLANK DISPLAY. CUSTOMER STATES THE DISPLAY DID NOT RETURN. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791553 530G INSULIN PUMP MMT-751NAL ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAL A4751NALJ 00643169503694

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR