BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 8113878 · Received November 28, 2018

    Report

    Report Number
    2531779-2018-20136
    Event Type
    Malfunction
    Date Received
    November 28, 2018
    Report Date
    November 23, 2018
    Manufacturer
    ANIMAS LLC
    Product Code
    OYC
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 20-DEC-2018 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX AND ALARM HISTORY SHOWED MULTIPLE CALL SERVICE 052/064/078/087 ALARMS. EVIDENCE OF MOISTURE CORROSION WAS OBSERVED ON THE DISPLAY SCREEN INSIDE THE PUMP. THE LEAK TEST FAILED DUE A BATTERY COMPARTMENT LEAK. THE PUMP POWERED UP TO A BLANK SCREEN UPON START UP. THE ALLEGED CALL SERVICE ALARM ISSUE WAS UNABLE TO BE ADEQUATELY INVESTIGATED DUE TO THE BLANK DISPLAY. THE PUMPS COVER WAS REMOVED, AND FURTHER MOISTURE CORROSION WAS FOUND TO THE POWER PRINTED CIRCUIT BOARD AND TO THE DISPLAY CIRCUIT AND TO THE KEYPAD FLEX/CONNECTOR.

    Description of Event or Problem · 1

    ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THERE WAS A CALL SERVICE ALARM. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE MAY RESULT IN A LONG-TERM CESSATION OF INSULIN DELIVERY IF THE USER IS UNABLE TO RESOLVE THE ALARM. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    949109 ANIMAS VIBE INSULIN INFUSION PUMP OYC ANIMAS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR