BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3850086 · Received June 4, 2014

    Report

    Report Number
    2531779-2014-15800
    Event Type
    Malfunction
    Date Received
    June 4, 2014
    Report Date
    May 30, 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

    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 07/21/2014-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/09/2014 WITH THE FOLLOWING FINDINGS:A REVIEW OF THE PUMP BLACK BOX DATA REVEALED CS 078-0008 AND 064-0008 CALL SERVICE ALARMS WERE RECORDED. DURING TESTING, A CS 078-0008 CALL SERVICE ALARM WAS EMITTED DURING AN ATTEMPTED REWIND STEP. THE PUMP COULD NOT BE EXERCISED FOR 24 HOURS DUE TO THE CS 078 CALL SERVICE ALARM. THE PUMP CASE WAS REMOVED, AND THE MOTOR DRIVE FLEX WAS NOT FULLY INSERTED IN THE CONNECTOR. THE FLEX WAS REINSERTED PROPERLY, AND THE PUMP WAS REWOUND WITH NO ALARMS.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CS 064) ISSUE. 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
    326783 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR