BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS VIBE

    MDR report key: 3331255 · Received September 6, 2013

    Report

    Report Number
    2531779-2013-14777
    Event Type
    Injury
    Date Received
    September 6, 2013
    Report Date
    August 14, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 PUMP WAS RETURNED TO ANIMAS CORPORATION ON 30 AUG 2013 AND WAS EXAMINED BY A CROSS-FUNCTIONAL INVESTIGATION TEAM. VISUAL, X-RAY, AND ELECTRO-MECHANICAL SYSTEM EVALUATIONS WERE COMPLETED AS PART OF THIS INVESTIGATION. THE PHYSICAL DAMAGE TO THE PUMP WAS CONSISTENT WITH A BRIEF, HIGH INTENSITY, THERMAL EVENT. THE ELECTRONIC CIRCUITRY OF THE PUMP WAS TRANSFERRED INTO A TEST BASE AND FOUND TO BE OPERABLE. VISUAL AND X-RAY EVALUATIONS OF THE BATTERY INDICATED A HIGH TEMPERATURE, HIGH PRESSURE RUPTURE. AS A RESULT OF ALL EVALUATIONS, THE TEAM CONCLUDED THAT A HIGH TEMPERATURE, HIGH PRESSURE RUPTURE OF THE BATTERY WAS THE CAUSE OF THE OBSERVED DAMAGE.

    Additional Manufacturer Narrative · 1

    (B)(6). THE PUMP HAS BEEN RETURNED TO ANIMAS BUT EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION 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. ICE.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013 INDICATING THAT THE PATIENT WAS BURNED ON THEIR STOMACH AFTER THE PUMP ALLEGEDLY EXPLODED. THE PATIENT REPORTEDLY HAD BURNS ON THEIR CLOTHES AND SKIN AND WAS TREATED AT A DIABETES CENTER. THIS INCIDENT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT WAS TREATED FOR BURNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444839 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R