BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3983092 · Received August 6, 2014

    Report

    Report Number
    2531779-2014-22527
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Report Date
    July 30, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED, AND IT WAS EVALUATED BY PRODUCT ANALYSIS ON 09/20/2014 WITH THE FOLLOWING FINDINGS: THE DATES FROM THE BLACK BOX DATA WERE INACCURATE DUE TO INCORRECT TIME AND DATE SETTINGS. LOW BATTERY WARNINGS, REPLACE BATTERY ALARMS, AND INEXPLICABLE REBOOT EVENTS WERE OBSERVED IN THE BLACK BOX DATA; THESE FINDINGS ARE POTENTIALLY INDICATIVE OF THE REPORTED EVENT. EVIDENCE OF MOISTURE INGRESS WAS OBSERVED INSIDE OF THE BATTERY COMPARTMENT AND ON THE UNDERSIDE OF THE BATTERY CAP. THE PUMP WAS EXPERIENCING AN INTERMITTENT-POWER ISSUE WITH THE RETURNED BATTERY CAP, WHICH WAS ABLE TO SECURE TO THE PUMP PER THE INSTRUCTIONS FOR USE (IFU). THUS A TEST BATTERY CAP WAS USED DURING ALL STEPS OF THE ANALYSIS. EVALUATION REVEALED THAT THE PUMP DREW ELECTRICAL CURRENT WITHIN THE SPECIFICATIONS; THE REPORTED EVENT WAS NOT DUPLICATED. THE PUMP PASSED A LEAK TEST. THE PUMP CASE WAS REMOVED, AND ADDITIONAL EVIDENCE OF MOISTURE INGRESS WAS OBSERVED IN THE AREA OF THE BATTERY COMPARTMENT CONTACT. THE RELATION OF THE MOISTURE INGRESS EVENT TO THE REPORTED EVENT COULD NOT BE DETERMINED, AS THE REPORTED EVENT WAS NOT DUPLICATED. 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.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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 POWER (BATTERY LIFE) 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
    461311 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1