BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3250455 · Received July 26, 2013

    Report

    Report Number
    2531779-2013-11958
    Event Type
    Malfunction
    Date Received
    July 26, 2013
    Date of Event
    July 3, 2013
    Report Date
    July 3, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    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. 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 BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/26/2012 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX HISTORY REVEALED MULTIPLE CALL SERVICE ALARMS ON THE REPORTED EVENT DATE. THE PUMP HISTORY INDICATED THAT THE LAST BASAL DELIVERY WAS ON (B)(6) 2013 AT 7:52AM AND DELIVERY WAS NEVER RESUMED. NO DAMAGE WAS FOUND TO THE BATTERY COMPARTMENT OR BATTERY CAP; BOTH MAINTAINED ELECTRICAL CONNECTION. THE PUMP WAS ABLE TO SUCCESSFULLY POWER ON; THE DISPLAY SCREEN REMAINED BLANK. THE AUDITORY AND VIBRATORY FEATURE WAS FOUND TO BE FUNCTIONING ON THE PUMP. NO INTERMITTENT POWER ISSUES WERE NOTED TO THE POWER CIRCUIT. THE PUMP¿S COVER WAS REMOVED AND AN ELECTRICAL COMPONENT FAILURE WAS NOTED ON THE PRINTED CIRCUIT BOARD (PCB). 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

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS STATING WHEN THE PATIENT AWOKE THERE WAS NO POWER TO THE PUMP AND THE PATIENT EXPERIENCED A BLOOD GLUCOSE (BG) VALUE OF 26 MMOL/L WITH SEVERE FREQUENT URINATION AND THIRST. THE PATIENT REPORTEDLY WAS TREATED WITH 4 UNITS OF INSULIN VIA SYRINGE. IT WAS NOTED THAT THE REPORTER TRIED DIFFERENT BATTERIES FROM DIFFERENT PACKAGES AND THE PUMP STILL WOULD NOT POWER ON. THE REPORTER STATED THAT THE PATIENT'S DIABETES IS MANAGED AT HOME AND THE PUMP SETTINGS ARE BEING ADJUSTED WITHOUT ASSISTANCE FROM THE HEALTH CARE PROVIDER (HCP). THE REPORTER DENIED THAT THERE WAS DAMAGE OR MOISTURE TO THE PUMP. THE BATTERY CAP REPORTEDLY WAS REPLACED AND THERE WAS NO VISIBLE YELLOW O-RING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED A HYPERGLYCEMIC EVENT WHILE USING INSULIN PUMP THERAPY AND DUE TO THE ALLEGATION THERE WAS A POWER ISSUE WITH THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349555 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR