BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4431197 · Received January 19, 2015

    Report

    Report Number
    2531779-2015-02034
    Event Type
    Malfunction
    Date Received
    January 19, 2015
    Report Date
    January 5, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE DEVICE WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 02/06/2014 WITH THE FOLLOWING FINDINGS: THE COMPLAINT COULD NOT BE DUPLICATED OR CONFIRMED WITH THE INVESTIGATION. A TEST PUMP WAS ABLE TO SUCCESSFULLY PAIR TO THE METER. THE METER ACCURATELY CALCULATED A BOLUS.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE REPORTER CONTACTED ANIMAS ALLEGING THE METER¿S BOLUS CALCULATING FEATURE WAS DISCREPANT FROM THE PUMP¿S BOLUS CALCULATING FEATURE. IT WAS REPORTED THE PATIENT¿S BLOOD GLUCOSE WAS BETWEEN 250-499 MG/DL WITHOUT SIGNS OR SYMPTOMS OF HYPERGLYCEMIA. THE REPORTED HEALTH EVENT DOES NOT QUALIFY AS A SERIOUS INJURY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE REMAINED UNRESOLVED AT THE TIME OF TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43318 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR