BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3855000 · Received June 9, 2014

    Report

    Report Number
    2531779-2014-16163
    Event Type
    Malfunction
    Date Received
    June 9, 2014
    Report Date
    May 19, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 11/06/2014-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: 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. A REVIEW OF THE PUMP BLACK BOX DATA AND HISTORIES REVEALED NO EVIDENCE RELATED TO THE COMPLAINT. DURING TESTING, THE PUMP WAS EXERCISED FOR 24 HOURS. THE BATTERY WAS REMOVED AND REINSERTED, AND THE ESTABLISHED SETTINGS WERE MAINTAINED. NO DEFECT WAS FOUND.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY/SETTINGS ISSUE. IT WAS REPORTED THAT THE PUMP WAS NOT HOLDING THE SETTINGS WHEN THE BATTERY WAS REMOVED. THE PATIENT REPORTEDLY HAD FREQUENT HIGHS AND LOWS IN BLOOD GLUCOSE VALUES WITH NO SYMPTOMS INDICATED, WHICH DOES NOT MEET THE ANIMAS CRITERIA FOR AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335440 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR