BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 2955716 · Received February 11, 2013

    Report

    Report Number
    2531779-2013-01670
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 22, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 04/23/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE PUMP WAS OPENED AND THE KEYPAD FLEX AND CONNECTOR HAD MOISTURE RESIDUE ON THEM. INVESTIGATORS WERE UNABLE TO OBTAIN AUDIBLE READING DUE TO UNRESPONSIVE CONTRAST BUTTON. INVESTIGATION CONFIRMED THAT THE THERE WAS NO RESPONSE TO BUTTON PRESSES ON OK AND CONTRAST BUTTONS. THE UP AND DOWN BUTTONS RESPONDED APPROPRIATELY. THERE WAS NO VISIBLE DAMAGE TO THE KEYPAD. THE KEYPAD WAS REMOVED TO CHECK CONDITION OF THE BUTTON CONTACTS AND THERE WAS NO CONTAMINATION OR OTHER ANOMALIES FOUND. THE KEYPAD SYMBOLS WERE FOUND TO BE WORN, WHICH HAS NO EFFECT ON INSULIN DELIVERY.

    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.

    Description of Event or Problem · 1

    THE DISTRIBUTOR CONTACTED ANIMAS ON (B)(6) 2013 ALLEGING THE UP ARROW, DOWN ARROW AND OK KEYPAD BUTTONS WERE UNRESPONSIVE. NO FURTHER INFORMATION IS AVAILABLE. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED MALFUNCTION REMAINED UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58797 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANIMAS VIBE INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1