BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP MMT-551NAB

    MDR report key: 8077320 · Received November 16, 2018

    Report

    Report Number
    2032227-2018-61824
    Event Type
    Malfunction
    Date Received
    November 16, 2018
    Date of Event
    November 1, 2018
    Report Date
    February 4, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    00643169503625
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A TEST RESERVOIR WAS INSTALLED AND DID NOT LOCK IN PLACE DUE TO COMPLETELY BROKEN RESERVOIR TUBE LIP. UNABLE TO PERFORM THE DISPLACEMENT TEST DUE TO COMPLETELY BROKEN RESERVOIR TUBE LIP. INSULIN PUMP HAD MISSING RESERVOIR TUBE O-RING.

    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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD DAMAGED. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTED THAT THE RESERVOIR LIP PLASTIC PIECE CRACKED OFF. THE CUSTOMER REPORTED THAT THE LOCATION OF DAMAGE WAS TOP OF THE INSULIN PUMP. THE CUSTOMER REPORTED THAT THE RESERVOIR ABLE TO LOCK IN PLACE BUT NOT SURE. 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 BACK UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    917012 530G INSULIN PUMP MMT-551NAB ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAB A4551NABJ 00643169503625

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR