BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 7840491 · Received September 3, 2018

    Report

    Report Number
    2531779-2018-15844
    Event Type
    Malfunction
    Date Received
    September 3, 2018
    Report Date
    August 12, 2018
    Manufacturer
    ANIMAS LLC
    Product Code
    OYC
    UDI-DI
    10840406103168
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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: DURING INVESTIGATION, THE -BATTERY COMPARTMENT AND CAP ARE UNDAMAGED AND ABLE TO FIT. THE PUMP POWERS UP WITH AUDITORY AND VIBRATION TO A BLANK SCREEN. THE PUMP¿S COVER WAS REMOVED, NO INTERMITTENT CONDITION WAS FOUND TO THE PCB. TEST CODE DOWNLOADER TOOL APPLICATION V 1.0.0 WAS USED TO UPLOAD TEST CODE V 1.1.12 TO MASTER/SLAVE/PERIPH PROCESSORS AS PER (6000975). THE UPLOAD WAS SUCCESSFUL, THE PUMP POWERS UP AND DISPLAY JUST ¿MSP¿ INSTEAD OF ¿MSP2¿. (2) IS THE EEPROM COMMUNICATING PROPERLY HENCE THE DIAGNOSIS THAT THE FAILURE IS IN THIS AREA SINCE IT IS MISSING FROM THE DISPLAY. EEPROM FAILURE IS CONCLUDED.

    Description of Event or Problem · 1

    ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (NO POWER) ISSUE. THE REPORTED DENIED DAMAGE TO THE PUMP OR THE BATTERY CAP AND CONFIRMED THAT THE BATTERY CAP FIT PROPERLY TO THE PUMP WITHOUT THE YELLOW O-RING VISIBLE. THERE IS NO INDICATION THE ALLEGED PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE USER MAY BE UNAWARE THAT THE PUMP HAS LOST POWER, LEADING TO UNDER DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681649 ANIMAS VIBE INSULIN INFUSION PUMP OYC ANIMAS LLC 10840406103168

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR