BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 6059992 · Received October 27, 2016

    Report

    Report Number
    2531779-2016-29815
    Event Type
    Malfunction
    Date Received
    October 27, 2016
    Report Date
    October 21, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    OYC
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 01/27/2017 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 01/03/2017 WITH THE FOLLOWING FINDINGS: THE PUMP WAS DELIVERING THE PROGRAMMED BASAL RATE UNTIL IT ALARMED WITH ¿CS052¿ SLAVE PROCESSOR COMMUNICATION ALARM ON (B)(6) 2016 @ 3:12 PM. THE PUMP WAS REBOOTED AND DELIVERIES WERE NEVER RESUMED AT POWER UP. NO ¿CS052¿ ALARM OR ANY EAW OCCURRED DURING THE INVESTIGATION, UNABLE TO DUPLICATE ¿CS052¿ COMPLAINT. THE PUMP¿S COVER WAS REMOVED, FURTHER MOISTURE INGRESS WAS FOUND TO THE PCB AND TO THE CGM MODULE. 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 NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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

    ON (B)(6) 2016, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CS 052/053/054/055 SLEEP) ISSUE. THE REPORTER STATED THAT STATED THAT THE PATIENT HAD A BLOOD GLUCOSE (BG) OF 270MG/DL WITH POLYDIPSIA AND IRRITABILITY. THE PATIENT DID NOT RECEIVE ANY TREATMENT ABOVE AND BEYOND THE USUAL ROUTINE CARE OF DIABETES MANAGEMENT. THIS REPORTED EVENT DOES NOT MEET THE ANIMAS CRITERIA FOR A SERIOUS ADVERSE EVENT. THIS REPORT IS BEING MADE DUE TO THE ALLEGED CALL SERVICE ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713750 ANIMAS VIBE INSULIN INFUSION PUMP OYC ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR