BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 4113642 · Received September 24, 2014

    Report

    Report Number
    2531779-2014-27290
    Event Type
    Malfunction
    Date Received
    September 24, 2014
    Report Date
    September 11, 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 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

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE CUSTOMER COMPLAINT OF A TORN/PUNCTURED AUDIO BOLUS BUTTON WAS UNABLE TO BE DUPLICATED AND WAS NOT OBSERVED. THE KEYPAD WAS FOUND TO BE TORN NEXT TO UP SYMBOL. ALL BUTTONS FUNCTIONED NORMALLY WHEN TESTED. THE KEYPAD WAS REMOVED AND EVIDENCE OF CONTAMINATION WAS OBSERVED UNDER THE UP AND DOWN CONTACTS. UNRELATED TO THE INITIAL COMPLAINT, THE DISPLAY WAS OBSERVED TO BE FADED AND THE LETTERS HAD A REDDISH TINT.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (ABB TACTILE CNG PRIOR TO DMG) ISSUE. THE REPORTER STATED THAT THE AUDIO BOLUS BUTTON WAS TORN AND UNRESPONSIVE. NO ADDITIONAL INFORMATION WAS AVAILABLE. 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
    595338 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1