BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 7254081 · Received February 8, 2018

    Report

    Report Number
    3004209178-2018-49508
    Event Type
    Malfunction
    Date Received
    February 8, 2018
    Date of Event
    January 15, 2018
    Report Date
    March 7, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    00643169939219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    PUMP NOT RECEIVED IN STUCK MANUFACTURING MODE. UNABLE TO PERFORM THE DISPLACEMENT TEST AND OCCLUSION TEST DUE TO MISSING RETAINER. UNIT RECEIVED WITH MISSING RESERVOIR TUBE O-RING, SCRATCHED CASE, PILLOWING KEYPAD OVERLAY AND MINOR SCRATCHED LCD WINDOW.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE RESERVOIR COMPARTMENT'S LIP PLASTIC PIECE ON TOP OF THE INSULIN PUMP KEPT FALLING AND CUSTOMER COULD SEE THE O-RING. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTED THAT PLASTIC PIECE KEPT SLIDING UP AND DOWN AND THAT WAS CONNECTED TO THE RESERVOIR LIP ON INSULIN PUMP CASE. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACK-UP PLAN. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED AND AGREED TO RETURN THE INSULIN PUMP FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101789 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG1ZV3Z 00643169939219

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR