BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3935389 · Received July 15, 2014

    Report

    Report Number
    2531779-2014-20108
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Report Date
    June 30, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/30/2014 WITH THE FOLLOWING FINDINGS: THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED AT THE OPENING OF THE BATTERY CHAMBER. THE RETURNED BATTERY CAP WAS ABLE TO FULLY TIGHTEN UNTIL THE O-RING WAS SEATED AND THE CAP WAS FLUSH WITH THE PUMP CASE. THERE WAS NO ISSUE WITH LOSS OF POWER AND NO EVIDENCE OF MOISTURE DAMAGE IN THE BATTERY COMPARTMENT. UNRELATED TO THE INITIAL COMPLAINT, THE TEXT ON THE DISPLAY SCREEN WAS OBSERVED TO BE DIM, FADED AND DISCOLORED AT THE MAXIMUM CONTRAST SETTING. THE BOLUS BUTTON WAS FOUND TO BE HARD TO PUSH AND A HOLE WAS VISIBLE ON THE COVER. UPON FURTHER INVESTIGATION, THE WHITE SLUG UNDER THE COVER WAS FOUND TO BE MISALIGNED. 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.

    Additional Manufacturer Narrative · 1

    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. (B)(6).

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS ALLEGING A CASING CONDITION ISSUE. THE REPORTER STATED THAT THERE WAS A CRACK IN THE BATTERY COMPARTMENT. NO ADDITIONAL INFORMATION WAS AVAILABLE. THERE WAS NO INDICATION THAT THE PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE REMAINED UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413312 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1