BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4842740 · Received June 12, 2015

    Report

    Report Number
    2531779-2015-19666
    Event Type
    Malfunction
    Date Received
    June 12, 2015
    Report Date
    May 28, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS AT THE TIME OF THIS REPORT. 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: 09/17/2015, DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED TO ANIMAS AND EVALUATED ON 08/27/2015 WITH THE FOLLOWING FINDINGS: THE BASAL HISTORY SHOWED A 0.000U BASAL PROGRAM FROM 05/29/2015 TO 06/04/2015. THE BLACK BOX DATA FOR THESE DATES WAS NOT AVAILABLE DUE TO CONTINUED USE OF THE PUMP. THE PUMP WAS EXERCISED FOR 24HRS WITH A 1.0U/HR BASAL RATE WHICH WAS CORRECTLY RECORDED IN THE DEVICE HISTORY. THE ALLEGED COMPLAINT COULD NOT BE DUPLICATED. 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, A REPORTER CONTACTED ANIMAS ALLEGING THAT A PATIENT WAS EXPERIENCING HYPER AND HYPOGLYCEMIA. THE REPORTER DIDN'T PROVIDE ANY SPECIFIC BLOOD GLUCOSE VALUES AT THE TIME OF CONTACT, OR ANY SYMPTOMS OF BLOOD GLUCOSE EXCURSIONS. THE REPORTED ISSUE DOES NOT MEET THE CRITERIA FOR A SERIOUS INJURY. THIS COMPLAINT IS BEING REPORTED BECAUSE A PUMP MALFUNCTION COULD NOT BE RULED OUT. CUSTOMER TECHNICAL SUPPORT WAS UNABLE TO CONTACT THE REPORTER TO COMPLETE TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385893 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR