BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1780KR 670G MG MEDI RECERT

    MDR report key: 10519503 · Received September 11, 2020

    Report

    Report Number
    2032227-2020-175388
    Event Type
    Malfunction
    Date Received
    September 11, 2020
    Date of Event
    August 30, 2020
    Report Date
    March 21, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000365912
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NEED TO CORRECT PRODUCT CODE FROM OYC TO OZP.

    Additional Manufacturer Narrative · 1

    DEVICE RECEIVED WITH CRITICAL PUMP ERROR AND PUMP ERROR 35 DUE TO MOISTURE DAMAGE TO FORCE SENSOR. DEVICE RECEIVED WITH CORRODED ELECTRONIC ASSEMBLIES AND CORRODED MOTOR HOME SWITCH. UNABLE TO PERFORM DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, OCCLUSION TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT AND SELF TEST DUE TO CRITICAL PUMP ERROR ALARM NOTED.

    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 INSULIN PUMP RECEIVED AN ALARM WHICH INDICATED THAT A BROKEN FORCE SENSOR WAS DETECTED DURING SEATING OR REGULAR DELIVERY. CUSTOMER WAS IN WATER WHEN INSULIN PUMP START BEEPING. CUSTOMER NOTICED THAT THE WATER WENT INTO THE BATTERY COMPARTMENT. SCREEN DID NOT APPEARED ON THE DISPLAY. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    984316 PUMP MMT-1780KR 670G MG MEDI RECERT PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KR HG4DHXT 000000763000365912

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR