BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3100846 · Received May 8, 2013

    Report

    Report Number
    2531779-2013-06054
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Report Date
    April 13, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 (B)(4) ¿ DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THERE WAS NO DATA FROM THE DATE OF THE EVENT DUE TO CONTINUED PATIENT USE. THE HISTORY SHOWED THAT THE TIME AND DATE WERE MANUALLY MANIPULATED ON (B)(4) 2013 LEADING THE TOTAL DAILY DOSE TO RECORD THAT DATE TWICE. THE PUMP WAS EXERCISED FOR 5 DAYS AND CONFIRMED THAT NO TIME CHANGES OCCURRED DURING TESTING. THE PUMP WAS POWERED OFF FOR 3 HOURS AND THE PUMP TIME AND DATE WERE CONFIRMED TO BE MAINTAINED ACCURATELY IN THE PUMP. NO PUMP DEFECTS WERE FOUND RELATED TO THE EVENT. 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

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013 AND WHILE TROUBLESHOOTING AN UNRELATED ISSUE NOTED THAT THE TIME AND DATE WERE SET INCORRECTLY IN THE PUMP. THE TIME/DATE AT THE TIME OF THE CALL WAS 5:40PM (B)(6) AND PUMP WAS SET AT 5:40AM (B)(6). THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE TIME/DATE ISSUE WASN'T RESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200723 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR