BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3930097 · Received July 11, 2014

    Report

    Report Number
    2531779-2014-19784
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Report Date
    July 4, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 3/20/15 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 03/10/2015 WITH THE FOLLOWING FINDINGS: BLACK BOX INFORMATION FROM DATE OF EVENT HAS BEEN OVERWRITTEN. UNABLE TO CONFIRM OR DUPLICATE THE COMPLAINT DURING INVESTIGATION. PUMP POWERS WITH RETURNED BATTERY CAP. BATTERY CAP IS ABLE TO FULLY TIGHTEN. BATTERY COMPARTMENT INTACT. NO ALARMS OBSERVED IN ALARM HISTORY. CURRENT DRAWS WITHIN SPECIFICATIONS. NO "BATTERY LIFE" ISSUES DUPLICATED DURING THE INVESTIGATION. REMOVED PUMP CASE. NO EVIDENCE OF MOISTURE OR LOOSE COMPONENTS INSIDE PUMP. 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 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
    407550 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR