BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3981714 · Received August 5, 2014

    Report

    Report Number
    2531779-2014-22475
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Report Date
    July 22, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: DUE TO INTERNAL MOISTURE CONTAMINATION, THE PUMP POWERED ON WITH THE RETURNED BATTERY CAP TO AN AUDIBLE TONE, VIBRATION AND A BLANK DISPLAY. THE BATTERY COMPARTMENT WAS INTACT. BATTERY CAP WAS ABLE TO FULLY TIGHTEN. THERE WAS EVIDENCE OF MOISTURE CONTAMINATION ON THE UNDERSIDE OF THE BATTERY CAP. THE PUMP PASSED A LEAK TEST. THERE WAS EVIDENCE OF MOISTURE CONTAMINATION INSIDE THE PUMP ON THE DISPLAY CABLE AND CONNECTOR. 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 CASING CONDITION ISSUE. THE REPORTER STATED THAT THERE WAS MOISTURE INGRESS IN THE PUMP. NO ADDITIONAL INFORMATION WAS AVAILABLE. THERE WAS NO INDICATION THAT THE PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE REMAINED UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456768 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR