BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4131807 · Received October 1, 2014

    Report

    Report Number
    2531779-2014-28009
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Report Date
    September 21, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    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

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED, AND IT WAS EVALUATED BY PRODUCT ANALYSIS ON 10/13/2014 WITH THE FOLLOWING FINDINGS: CS-054 CALL SERVICE ALARMS, WHICH CAN BE INDICATIVE OF THE EVENT TYPE REPORTED, WERE OBSERVED IN THE HISTORY AND BLACK BOX DATA. THE PUMP WAS EXERCISED FOR 24 HOURS, DURING WHICH NO CS-054 CALL SERVICE ALARMS WERE OBSERVED: THE REPORTED EVENT WAS NOT DUPLICATED. THE PUMP CASE WAS REMOVED, AND NO INTERNAL DAMAGE OR DEFECT WAS FOUND. UNRELATED TO THE REPORTED EVENT, THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED IN TWO PLACES; HOWEVER, NO EVIDENCE OF MOISTURE INGRESS WAS OBSERVED DURING THE INVESTIGATION.

    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
    612718 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR