BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 4138022 · Received October 3, 2014

    Report

    Report Number
    2531779-2014-28290
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Report Date
    September 24, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION FOLLOW-UP #1 SUBMITTED (B)(4) 2014: THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING RESULTS: NO DEFECT WAS FOUND. NO ALARM OR ANY LOUD SCREECHING NOISE OCCURRED DURING THE INVESTIGATION, THE PRODUCT PERFORMS WITHIN SPECIFICATION. TESTING WAS UNABLE TO DUPLICATE ¿ LOUD SCREECHING NOISE ¿ COMPLAINT. THE KEYPAD IS UNDAMAGED AND ALL BUTTONS RESPOND PROPERLY. LAST BASAL DELIVERY WAS ON (B)(6) 2014@11:41AM, BLACK BOX SHOWS SEVERAL ¿160/247¿ SUSPEND WARNINGS ON (B)(6) 2014, NO ACTIVITY OUTSIDE OF NORMAL USE IS 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

    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).

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING THE PUMP WAS MAKING HIGH-PITCHED SCREECHING NOISES EVERY COUPLE OF MINUTES. THE PUMP SCREEN REMAINED NORMAL ON THE HOME SCREEN. 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
    618036 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1