BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3112488 · Received May 14, 2013

    Report

    Report Number
    2531779-2013-06413
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Report Date
    April 17, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER CAREGIVERS

    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

    SERIAL # (B)(4).

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL IS TO CORRECT THE BRAND NAME AND MODEL NUMBER FOR THIS PRODUCT.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 3 DATE OF SUBMISSION 26-NOV-2017. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 02-NOV-2017 WITH THE FOLLOWING FINDINGS: DURING TESTING, THE PUMP POWERED ON NORMALLY AND THE PUMP¿S ¿EZ-PRIME¿ STEPS WERE PERFORMED CORRECTLY. THE PUMP WAS EXERCISED FOR 24 HOURS AND NO ERRORS, ALARMS OR WARNINGS OCCURRED. THE PUMP DID NOT RANDOMLY GO TO THE PRIME SCREEN DURING TESTING. THERE WERE NO HYPERSENSITIVE OR STUCK KEYPAD BUTTONS ON THE KEYPAD. THE INVESTIGATION DID NOT DUPLICATE THE COMPLAINT. UNRELATED TO THE ORIGINAL COMPLAINT, IT WAS OBSERVED THAT THE BATTERY COMPARTMENT WAS CRACKED AND THE DISPLAY SCREEN WAS DISCOLORED. 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 ANIMAS REPRESENTATIVE CONTACTED ANIMAS ON (B)(6) 2013 ALLEGING THAT THE AUDIO BOLUS BUTTON ON THE PUMP WAS MISSING. A DAMAGED AUDIO BOLUS BUTTON WILL PERMIT CONTAMINATION TO PERMEATE THE BUTTON WHICH WILL HAVE A NEGATIVE IMPACT ON BUTTON FUNCTION. THIS SITUATION IS NOT LIKELY TO RESULT IN AN ADVERSE EVENT AS THE BUTTON SHOULD BE CLEARLY VISIBLE AND PROHIBIT THE USE OF THE BUTTON. 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 AUDIO BOLUS BUTTON DAMAGE REMAINED UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212066 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1