BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4240975 · Received November 10, 2014

    Report

    Report Number
    2531779-2014-32037
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Report Date
    October 26, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED, AND IT WAS EVALUATED BY PRODUCT ANALYSIS ON 01/08/2015 WITH THE FOLLOWING FINDINGS: SEVERAL CS-054 'CALL SERVICE ALARMS', WHICH CAN BE INDICATIVE OF THE TYPE OF ISSUE THAT WAS REPORTED, WERE OBSERVED IN THE PUMP HISTORY AND BLACK BOX DATA. THE PUMP WAS EXERCISED FOR 24 HOURS, DURING WHICH NO CS-054 'CALL SERVICE ALARMS' WERE OBSERVED: THE REPORTED ISSUE WAS NOT DUPLICATED. DURING THE ANALYSIS, THE PUMP OPERATED ACCORDING TO THE SPECIFICATIONS.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CS 052/053/054/055 SLEEP) ISSUE. IT WAS REPORTED THAT A CS-054 CALL SERVICE ALARM OCCURRED 3 OR MORE TIMES WITHIN A 30 DAY PERIOD. 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
    722457 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR