BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP MMT-751NAP

    MDR report key: 8703250 · Received June 17, 2019

    Report

    Report Number
    2032227-2019-17107
    Event Type
    Malfunction
    Date Received
    June 17, 2019
    Date of Event
    June 6, 2019
    Report Date
    July 30, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    00643169503700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RECEIVED WITH BROKEN BATTERY TUBE THREADS AND BROKEN RESERVOIR TUBE LIP. (B)(4).

    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS DAMAGED. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 219 MG/DL. CUSTOMER ALSO STATED THAT THE THREADS OF BATTERY COMPARTMENT WAS BROKEN OFF AND THE CASING AROUND THE THREADS. RESERVOIR WAS ABLE TO LOCK IN PLACE BUT, HALF OF THREADS FOR RESERVOIR ARE BROKEN OFF. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACKUP PLAN. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496687 530G INSULIN PUMP MMT-751NAP ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAP A4751NAPJ 00643169503700

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR