BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 2970378 · Received February 20, 2013

    Report

    Report Number
    2531779-2013-01955
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 29, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECT MEDICAL DEVICE: THE INITIAL REPORT WAS INADVERTENTLY SUBMITTED WITH THE INCORRECT PUMP ¿BRAND NAME¿. THE SUSPECT MEDICAL DEVICE ¿BRAND NAME¿ HAS BEEN UPDATED TO ANIMAS VIBE. THE INVESTIGATION PREVIOUSLY REPORTED WAS FOR THE CORRECT PUMP.ANIMAS VIBE

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL IS TO CORRECT THE MODEL NUMBER FOR THE PRODUCT.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION (B)(4) 2013- DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE KEYPAD WAS PEELING AND LIFTING NEAR THE CONTRAST BUTTON, EXPOSING THE BUTTON CONTACT. DURING TESTING, ALL KEYPAD BUTTONS RESPONDED APPROPRIATELY. DURING INVESTIGATION, THE KEYPAD WAS REMOVED AND NO CONTAMINATION OR DEFECT WAS FOUND.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 KEYPAD WAS PEELING/TORN/WORN AND THAT THE CONTRAST BUTTON WAS UNRESPONSIVE. A DAMAGED KEYPAD WILL PERMIT CONTAMINATION TO PERMEATE THE BUTTONS WHICH WILL HAVE A NEGATIVE IMPACT ON BUTTON FUNCTION. THIS SITUATION IS NOT LIKELY TO RESULT IN AN ADVERSE EVENT AS THE DAMAGED KEYPAD SHOULD BE CLEARLY VISIBLE AND WARNS THE PATIENT TO DISCONTINUE USING THE PUMP. THE CONTRAST BUTTON HAS NO AFFECT ON INSULIN DELIVERY. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. NO FURTHER INFORMATION WAS AVAILABLE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE KEYPAD ISSUE REMAINED UNRESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73352 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1