BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3221213 · Received July 11, 2013

    Report

    Report Number
    2531779-2013-10326
    Event Type
    Malfunction
    Date Received
    July 11, 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

    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: REVIEW OF THE BLACK BOX DATA REVEALED INFORMATION FROM THE REPORTED TIME OF EVENT HAD BEEN OVERWRITTEN DUE TO CONTINUED PATIENT USE. REVIEW OF THE DOWNLOAD HISTORY REVEALED ONE OCCLUSION ALARM IN THE ALARM HISTORY ON 06/24/2013. ON INVESTIGATION, A REWIND, LOAD A PRIME SEQUENCE WAS EXECUTED SUCCESSFULLY WITHOUT ALARM. THE PUMP WAS EXERCISED FOR 24 HOURS WITHOUT ALARM. THE FORCE SENSOR WAS EVALUATED AND FOUND TO BE WITHIN SPECIFICATIONS. AN OCCLUSION WAS INDUCED DURING THE INVESTIGATION AND THE PUMP EMITTED THE APPROPRIATE AUDIBLE AND VISUAL ¿OCCLUSION DETECTED¿ ALARM. INVESTIGATION WAS UNABLE TO DUPLICATE THE COMPLAINT.

    Additional Manufacturer Narrative · 1

    (B)(6). 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT REPORTED THAT THE PUMP DID NOT ALARM FOR AN OCCLUSION WHEN THE CANNULA ON THE INFUSION SET WAS BENT AND NOT DELIVERING INSULIN PROPERLY. THE PATIENT REPORTED HYPERGLYCEMIA AS A RESULT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED PUMP MALFUNCTION REMAINED UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319750 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR