BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3942007 · Received July 17, 2014

    Report

    Report Number
    2531779-2014-20479
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Report Date
    June 30, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ASSET SERIAL NUMBER ADDED TO COMPLAINT.

    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. (B)(6).

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #3 DATE OF SUBMISSION 10/09/2014 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: INVESTIGATION REVEALED THAT THE DISPLAY SCREEN TEXT WAS DIM, FADED, AND DISCOLORED. THE PUMP WAS RETURNED WITH THE CONTRAST SETTING AT 7; DURING INVESTIGATION, THE CONTRAST WAS INCREASED TO THE MAXIMUM 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.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL IS TO CORRECT THE BRAND NAME, MODEL NUMBER, AND SERIAL NUMBER FOR THE PRODUCT. (B)(4).

    Description of Event or Problem · 1

    THE DISTRIBUTOR CONTACTED ANIMAS ON (B)(6) 2014 ALLEGING THE DISPLAY WAS DIM, FADED, DISCOLORED. THERE WAS NO HEALTH CONSEQUENCE TO THE PATIENT ASSOCIATED WITH THE REPORTED INCIDENT, AND NO MEDICAL TREATMENT OR HEALTH CARE PROVIDER INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418066 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1