BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3912693 · Received July 3, 2014

    Report

    Report Number
    2531779-2014-19053
    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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 08/28/2014-PRODUCT ANALYSIS:THE PUMP WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/14/2014 WITH THE FOLLOWING FINDINGS:THE COMPLAINT COULD NOT BE INVESTIGATED DUE TO FREQUENT REPLACE BATTERY ALARMS. A REVIEW OF THE BLACK BOX REVEALED RELATED REBOOTING EVENTS. A BATTERY COMPARTMENT CRACK WAS OBSERVED. THERE WAS NO MOISTURE OBSERVED WITHIN THE BATTERY COMPARTMENT OR BATTERY CAP. MOISTURE WAS VISIBLE BENEATH THE DISPLAY LENS. MOISTURE WAS OBSERVED ON THE PUMP¿S INTERNAL COMPONENTS. UNRELATED TO THE COMPLAINT, A DIM DISPLAY SCREEN WAS DISCOVERED DURING EVALUATION.

    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. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING AN INTERMITTENT POWER ISSUE WITH EVIDENCE OF MOISTURE WITHIN THE BATTERY COMPARTMENT. 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
    389144 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR