BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2032227-2019-123411

    MDR report key: 9382246 · Received November 27, 2019

    Report

    Report Number
    2032227-2019-123411
    Event Type
    Malfunction
    Date Received
    November 27, 2019
    Date of Event
    November 20, 2019
    Report Date
    February 17, 2020
    Product Code
    OYC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    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. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE 640G INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES.

    Additional Manufacturer Narrative · 1

    DEVICE PASSED THE REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST AND DISPLACEMENT TEST. NO UNEXPECTED PUMP ERROR 130 ALARM OR EXPOSED TO MAGNETIC FIELD NOTED DURING TESTING. DEVICE PASSED THE DELIVERY ACCURACY TEST.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP HAD INSULIN PUMP ERROR ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1180191 OYC

    Patients

    Seq Age Sex Outcome Treatment
    1