BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP MMT-751NAS

    MDR report key: 8665530 · Received June 4, 2019

    Report

    Report Number
    2032227-2019-10999
    Event Type
    Malfunction
    Date Received
    June 4, 2019
    Date of Event
    May 29, 2019
    Report Date
    July 4, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    00643169503717
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Additional Manufacturer Narrative · 1

    (B)(4). NO UNEXPECTED NO DELIVERY ALARM NOTED DURING TESTING. DEVICE PASSED REWIND TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST, EXCESSIVE NO DELIVERY TEST AND DISPLACEMENT TEST.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP RECEIVED PUMP ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 229 MG/DL. TROUBLESHOOTING WAS COMPLETED FOR NO DELIVERY ALARM. CUSTOMER STATES THEY HAD TRIED ALL REMEDIES. THE CUSTOMER WAS ALSO ADVISED REVERT TO BACK UP PLAN AND TREAT PER HEALTHCARE PROFESSIONAL¿S INSTRUCTIONS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459072 530G INSULIN PUMP MMT-751NAS ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS A4751NASJ 00643169503717

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR