BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 12555720 · Received September 30, 2021

    Report

    Report Number
    2032227-2021-200066
    Event Type
    Malfunction
    Date Received
    September 30, 2021
    Date of Event
    September 29, 2021
    Report Date
    January 14, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000283520
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER RING= BLACK. CUSTOMER COMPLAINED ON (B)(6) 2021 INSULIN PUMP ALARMED STUCK BUTTON. DEVICE PASSED SELF TEST AND DISPLACEMENT TEST. ALL BUTTONS FUNCTION PROPERLY, HOWEVER TRACES OF CORROSION WAS NOTED ON KEYPAD TRACES. DEVICE SUCCESSFULLY DOWNLOADED TO THUS. NO STUCK BUTTON ERROR ALARMS NOTED DURING TESTING. VERIFIED PUMP ALARMED STUCK BUTTON ON (B)(6) 2021 00:15:00.000 IN PUMP DOWNLOADED HISTORY. UNIT PASSED THE KEYPAD VOLTAGE TEST. NO DAMAGE WAS NOTED TO KEYPAD ASSEMBLY AND J1 CONNECTOR ON PCB1 WAS LOCKED PROPERLY DURING VISUAL INSPECTION. THE ELECTRONIC ASSEMBLIES WERE INSPECTED AND NO ANOMALIES NOTED. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: SCRATCHED CASE, PILLOWING KEYPAD OVERLAY AND CRACKED CASE (BATTERY TUBE). P-CAP/RESERVOIR LOCKS PROPERLY. NO STUCK BUTTON ERROR ALARMS NOTED DURING TESTING. VERIFIED PUMP ALARMED STUCK BUTTON ON (B)(6) 2021 00:15:00.000 IN INSULIN PUMP DOWNLOADED HISTORY. ALL BUTTONS FUNCTION PROPERLY, HOWEVER TRACES OF CORROSION WAS NOTED ON KEYPAD TRACES.

    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

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD KEYPAD ANOMALY. CUSTOMER REPORTED THAT THEY RECEIVED STUCK BUTTON ALARM. CUSTOMER STATED THAT THEY WERE UNABLE TO CLEAR THE ALARM. CUSTOMER STATED STUCK BUTTON ALARM HAPPENED WHEN A BUTTON WAS CONTINUALLY PRESSED FOR MORE THAN 3 MINUTES. CUSTOMER STATED THAT BUTTON WAS PRESSED FOR MORE THAN 3 MINUTES. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1449383 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG49C80 000000763000283520

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male