BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3911995 · Received July 3, 2014

    Report

    Report Number
    2531779-2014-19024
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Report Date
    June 28, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 09/10/2014-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP BLACK BOX DATA REVEALED A CS 078-0008 CALL SERVICE ALARM. DURING A VISUAL INSPECTION OF THE PUMP, MOISTURE WAS OBSERVED BEHIND THE DISPLAY LENS. THE PUMP CASING WAS ALSO CRACKED NEAR THE DISPLAY. DURING TESTING, THE PUMP EMITTED THE SAME CALL SERVICE ALARM WHILE THE REWIND STEP WAS ATTEMPTED. A LEAK TEST WAS PERFORMED AND FAILED DUE TO A LEAK AT THE CRACK IN THE CASING. THE PUMP CASE WAS REMOVED AND CORROSION DUE TO MOISTURE WAS FOUND ON THE MOTOR FLEX CONNECTOR.

    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 078) ISSUE. IT WAS REPORTED THAT THE PUMP EMITTED A CS 078 CALL SERVICE ALARM THREE TIMES IN THIRTY DAYS. 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
    389899 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR