BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3082205 · Received April 29, 2013

    Report

    Report Number
    2531779-2013-05469
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    March 18, 2013
    Report Date
    April 5, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE KEYPAD WAS CONFIRMED TO BE TORN BETWEEN THE UP ARROW AND CONTRAST KEYPAD BUTTONS. EVALUATION REVEALED THAT THE KEYPAD BUTTONS WERE RESPONSIVE TO USER INPUT. THERE WAS NO EVIDENCE OF CONTAMINATION FOUND UNDER THE KEY CONTACTS. UNRELATED TO THE COMPLAINT, THE BOLUS BUTTON WAS FOUND TO BE DETACHED FROM THE PUMP, EXPOSING THE KEY CONTACTS AND THEREFORE, THE AUDIBLE ALARM READING WAS UNABLE TO BE OBTAINED. 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.

    Description of Event or Problem · 1

    THE DISTRIBUTOR CONTACTED ANIMAS ON (B)(6) 2013, ALLEGING THE KEYPAD WAS PEELED/TORN/WORN. NO FURTHER INFORMATION WAS AVAILABLE. A DAMAGED KEYPAD RUBBER 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 RUBBER SHOULD BE CLEARLY VISIBLE AND PROHIBIT THE USE OF THE KEYPAD BUTTONS. USERS MAY EXPECT KEYPAD DAMAGE DURING NORMAL WEAR AND THE OWNER'S BOOKLET INSTRUCTS THE USER TO CONTACT CUSTOMER SERVICE IF THE USER SUSPECTS THE PUMP MAY BE DAMAGED. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED KEYPAD ISSUE REMAINED UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183420 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1