BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3030683 · Received April 2, 2013

    Report

    Report Number
    2531779-2013-03420
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Report Date
    March 6, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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. 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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE REPORTER LEFT A MESSAGE FOR ANIMAS ON (B)(6) 2013 REPORTING ELEVATED BLOOD GLUCOSE LEVELS IN THE MORNING HOURS BETWEEN 7 AM AND 12 AM. THE PATIENT INQUIRED IF THE ELEVATED BLOOD GLUCOSE WAS POSSIBLY RELATED TO AN ISSUE WITH THE METER REMOTE OR PUMP. THE REPORTER INDICATED HAVING ELEVATED BLOOD GLUCOSE LEVELS IN THE MORNING IN EXCESS OF 200 MG/DL. THE REPORTER INDICATED NOT HAVING THE ISSUE IN THE AFTERNOON OR EVENING. NO TROUBLESHOOTING WAS ABLE TO BE PERFORMED. ANIMAS HAS ATTEMPTED TO CONTACT THE PATIENT BUT HAVE BEEN UNSUCCESSFUL AT THIS TIME. THE PATIENT'S REPORTED BLOOD GLUCOSE LEVELS DO NOT MEET ANIMAS CRITERIA FOR AN ADVERSE EVENT. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT AN UNSPECIFIED PUMP ISSUE MAY HAVE BEEN CONTRIBUTING TO THE PATIENT'S ELEVATED BLOOD GLUCOSE LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134700 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR