BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3852521 · Received June 5, 2014

    Report

    Report Number
    2531779-2014-15990
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Report Date
    May 21, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    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).

    Additional Manufacturer Narrative · 1

    (B)(4). 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. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/14/2014 WITH THE FOLLOWING FINDINGS: ON EXAMINATION, THERE WAS VISIBLE MOISTURE BEHIND THE DISPLAY LENS, A BATTERY COMPARTMENT CRACK BELOW THE GRIP PAD AND A CRACK IN THE PUMP CASE ADJACENT TO THE KEYPAD. THERE WAS NO EVIDENCE OF MOISTURE CONTAMINATION INSIDE THE BATTERY COMPARTMENT. ON INVESTIGATION, THE PUMP POWERED ON WITH AUDIBLE AND VIBRATORY FUNCTION PRESENT; HOWEVER, THE DISPLAY SCREEN REMAINED BLANK. A LEAK TEST WAS PERFORMED AND REVEALED A MOISTURE LEAK AT THE CRACK IN THE CASE. ON INVESTIGATION, THE BATTERY CAP WAS ABLE TO BE SECURED PROPERLY TO THE PUMP. THE PUMP WAS OPENED FOR INVESTIGATION AND REVEALED EVIDENCE OF MOISTURE CONTAMINATION INSIDE THE PUMP. INVESTIGATION DID NOT DUPLICATE THE REPORTED ISSUE OF NO POWER TO THE PUMP.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (NO POWER) ISSUE. 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
    328813 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1