BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3781605 · Received April 30, 2014

    Report

    Report Number
    2531779-2014-11932
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Report Date
    April 17, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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. (B)(6).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: INVESTIGATION COULD NOT CONFIRM OR DUPLICATE THE ORIGINAL COMPLAINT. THE SCREEN WAS FULLY FUNCTIONAL WHEN THE PUMP WAS POWERED ON. A REVIEW OF THE ALARM HISTORY INDICATED MULTIPLE CALL SERVICE 052/054 ALARMS HAD OCCURRED AT THE TIME OF THE ALLEGED INCIDENT. THERE WAS NO INDICATION OF THE PUMP REBOOTING PRIOR TO THE ALARMS. UNRELATED TO THE COMPLAINT, THE DISPLAY SCREEN WAS OBSERVED TO BE DIM AND DISCOLORED AT THE CONTRAST SETTING OF 7; THE CONTRAST WAS INCREASED TO THE MAXIMUM SETTING OF 10 WITH LITTLE IMPROVEMENT OBSERVED. 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 DISTRIBUTOR CONTACTED ANIMAS ALLEGING THAT THE PUMP¿S DISPLAY SCREEN WAS BLANK. THE DISTRIBUTOR NOTED THAT AUDIBLE TONES WERE PRESENT UPON BATTERY INSERTION. THERE IS NO INDICATION THAT THE PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE REMAINED UNRESOLVED AT THE TIME OF TROUBLE SHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259750 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1