BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 4905234 · Received July 10, 2015

    Report

    Report Number
    2531779-2015-23112
    Event Type
    Malfunction
    Date Received
    July 10, 2015
    Report Date
    June 22, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    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).

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 08/19/2015. DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/28/2015 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, A VISUAL INSPECTION REVEALED THAT THE DISPLAY LENS WAS SCRATCHED. A REVIEW OF THE BLACK BOX HISTORY REVEALED A CS 087 CALL SERVICE ALARM. THE PUMP ALARMED WITH A CS 069 CALL SERVICE ALARM DURING START UP. A LANGUAGE CORRUPTION OCCURRED AT A COMPONENT ON THE PRINTED CIRCUIT BOARD RESULTING IN A CALL SERVICE ALARM. 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) 2015, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (DAMAGED) ISSUE. THE DISPLAY SCREEN WAS REPORTEDLY SCRATCHED. THERE NO ADDITIONAL INFORMATION AVAILABLE TO DETERMINE WHETHER OR NOT THE USER WAS ABLE TO THE READ THE DISPLAY SCREEN. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449659 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1