BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4168291 · Received October 14, 2014

    Report

    Report Number
    2531779-2014-29085
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Report Date
    September 30, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS METER REMOTE AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE METER REMOTE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: ON INVESTIGATION, THE REPORTED FOOD DATA BASE ISSUE WAS DUPLICATED. THE METER POWERED UP AND PERFORMED PROPERLY. THE FOOD DATA BASE (FDB) WAS DOWNLOADED FROM THE METER AND IT WAS CONFIRMED THAT THE RETURNED FDB WAS EMPTY. A DEFAULT FDB WAS SUCCESSFULLY UPLOADED TO THE RETURNED METER AND THE METER WAS ABLE TO MAINTAIN THE FDB. THE INVESTIGATION WAS ABLE TO ACCESS MULTIPLE FOOD ITEMS ON THE UPLOADED FDB.

    Additional Manufacturer Narrative · 1

    THE METER REMOTE HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A METER ERROR (METER ERROR ISSUE) ISSUE. REPORTEDLY, A PARTICULAR FOOD CATEGORY WAS NOT AVAILABLE IN THE METER FOOD DATA BASE. 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
    649693 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR