BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3844397 · Received June 2, 2014

    Report

    Report Number
    2531779-2014-15504
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Report Date
    May 27, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/10/2014 WITH THE FOLLOWING FINDINGS: CALL SERVICE ALARMS CS 054 WERE VERIFIED IN THE PUMP¿S BLACK BOX AND ALARM HISTORY. DURING TESTING, THE PUMP EMITTED A CS 054. THE PUMP SOFTWARE WAS RELOADED AND THE PUMP WAS TESTED WITHOUT FURTHER ALARMS. THE PUMP WAS OPENED, NO INTERNAL DEFECTS WERE OBSERVED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/10/2014 WITH THE FOLLOWING FINDINGS: CALL SERVICE ALARMS CS 054 WERE VERIFIED IN THE PUMP¿S BLACK BOX AND ALARM HISTORY. DURING TESTING, THE PUMP EMITTED A CS 054. THE PUMP SOFTWARE WAS RELOADED AND THE PUMP WAS TESTED WITHOUT FURTHER ALARMS. THE PUMP WAS OPENED, NO INTERNAL DEFECTS WERE OBSERVED. 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.

    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 MULTIPLE CALL SERVICE CS 054 ALARMS. 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
    321639 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR