BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3062300 · Received April 16, 2013

    Report

    Report Number
    2531779-2013-04377
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Report Date
    March 18, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX HISTORY REVEALED POWER INTERRUPTIONS ON (B)(4) 2013. A ¿LOW BATTERY¿ AND ¿REPLACE BATTERY¿ ALARM WAS NOTED IN PUMP HISTORY. THE PUMP WAS SUSPENDED FOR 1 WEEK BETWEEN (B)(4) 2013. A VISUAL INSPECTION REVEALED NO DAMAGE OR MOISTURE TO THE PUMP. THERE WAS NO DAMAGE TO THE BATTERY CAP; ELECTRICAL CONNECTION WAS MAINTAINED WITH NO ISSUES NOTED. THE PUMP POWERED ON TO THE ¿VERIFY¿ SCREEN WITH NO ISSUES. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO POWER ISSUES. A ¿LOW BATTERY¿ AND ¿REPLACE BATTERY¿ ALARM WAS INDUCED AND THE PUMP ALARMED APPROPRIATELY. THE REPORTED POWER ISSUE WAS NOT DUPLICATED DURING INVESTIGATION. 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 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. (B)(6).

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE DISTRIBUTER CONTACTED ANIMAS STATING THE PUMP'S DISPLAY SCREEN WAS BLANK. THE PUMP REPORTEDLY EMITTED AN "EMPTY BATTERY" ALARM. THE BATTERY WAS REPORTEDLY REPLACED AND THE PUMP POWERED ON WITH NO ISSUES. IT WAS NOTED THAT THE PATIENT'S BLOOD GLUCOSE MEASUREMENT WAS 4.254 G/L. THE REPORTED BG IS NOT INDICATIVE OF A SERIOUS INJURY AND DOES NOT MEET THE ANIMAS CRITERIA OF AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGED DISPLAY SCREEN ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162286 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1