BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 4221569 · Received November 3, 2014

    Report

    Report Number
    2531779-2014-31294
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Report Date
    October 17, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. 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 PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/19/2014 WITH THE FOLLOWING FINDINGS: DURING TESTING, THE PUMP WAS NOT ABLE TO BE POWERED ON DUE TO RUST IN THE BATTERY COMPARTMENT. THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED ABOVE THE GRIP PAD AND ALONG THE LEFT SIDE OF THE GRIP PAD. A LEAK TEST WAS PERFORMED AND A BATTERY COMPARTMENT AND KEYPAD LEAKS WERE FOUND. THE COMPLAINT THAT THE DISPLAY WAS BLANK WAS NOT ABLE TO BE ADEQUATELY INVESTIGATED DUE TO THE PUMP¿S INABILITY TO POWER ON. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (BLANK SCREEN W/MOISTURE) ISSUE. THE REPORTER ALLEGED THAT THE DISPLAY SCREEN WAS BLANK. IT WAS NOTED THAT THERE WAS MOISTURE/CORROSION IN THE BATTERY COMPARTMENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702568 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR