BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3372853 · Received September 27, 2013

    Report

    Report Number
    2531779-2013-16172
    Event Type
    Malfunction
    Date Received
    September 27, 2013
    Report Date
    September 6, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 06/01/2015. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 05/15/2015 WITH THE FOLLOWING FINDINGS: REVIEW OF THE BLACK BOX DATA AND DOWNLOAD HISTORY REVEALED THE LAST BASAL DELIVERY WAS RECORDED ON MARCH 21, 2915 AT 11:10 AM. THE DATE OF THE REPORTED EVENT WAS SEPTEMBER 6, 2013. DATA FROM THIS TIME PERIOD HAD BEEN OVERWRITTEN DUE TO CONTINUED PATIENT USE. THE BLACK BOX DATA REVEALED NO ACTIVITY OUTSIDE OF NORMAL USE. THE TOTAL DAILY DOSE AMOUNTS ADDED UP TO CORRECTLY REFLECT THE USER¿S PROGRAMMED BASAL RATE TARGET. ON INVESTIGATION, THE PUMP WAS EXERCISED FOR 24 HOURS WITHOUT ERROR, ALARM OR WARNING. THE INSULIN ON BOARD WAS TURNED ON AND SET TO 4.5 HOURS DURATION. A 10.0 UNIT NORMAL BOLUS WAS PROGRAMMED AND DELIVERED DURING THE INVESTIGATION. AT 8:03 AM, NO INSULIN ON BOARD WAS PRESENT BEFORE BOLUS DELIVER. AFTER 4 TO 4.5 HOURS, THE INSULIN ON BOARD REMAINING IN THE STATUS SCREEN STILL SHOWED 0.2 UNITS INSULIN ON BOARD REMAINING. THE COMPLAINT OF INSULIN ON BOARD NOT CALCULATING CORRECTLY WAS DUPLICATED. UNRELATED TO THE ORIGINAL COMPLAINT, THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED BELOW THE BUMPER PAD AND THE DISPLAY SCREEN WAS NOTED TO BE DIM, FADED, DISCOLORED.

    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.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 ALLEGING THE INSULIN-ON-BOARD (IOB) CALCULATION WAS LONGER THAN WHAT THE PUMP WAS PROGRAMMED FOR. THE PATIENT ALLEGED THAT THE IOB WAS TRACKING INSULIN REMAINING UP TO 6 HOURS, 10 MINUTES WHEN THE IOB IN THE PUMP IS SET FOR 4.5 HOURS. THE PATIENT DECLINED TO THE RETURN THE PUMP AND HAVE IT REPLACED. THE PATIENT STATE SHE HAS LEARNED TO LIVE WITH THIS PROBLEM AND CALCULATES THE IOB HERSELF MANUALLY TO DETERMINE THE CORRECT AMOUNT OF INSULIN TO BOLUS. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED IOB CALCULATION ISSUE REMAINED UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491115 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR