BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4192657 · Received October 22, 2014

    Report

    Report Number
    2531779-2014-29952
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Report Date
    October 9, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION: 01/20/2017. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 01/04/2017 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE DATA FROM THE DATE OF THE COMPLAINT HAD BEEN OVERWRITTEN. THE PUMP POWERED ON WITH THE RETURNED BATTERY CAP. THE BATTERY CAP WAS ABLE TO FULLY TIGHTEN. THERE WAS EVIDENCE OF MOISTURE CONTAMINATION FOUND INSIDE THE BATTERY COMPARTMENT. THE CURRENT DRAWS WERE WITHIN SPECIFICATION. A ¿BATTERY LIFE¿ ISSUE WAS NOT DUPLICATED DURING INVESTIGATION. A LEAK TEST SHOWED A BATTERY COMPARTMENT LEAK. THE PUMP CASE WAS REMOVED AND THERE WAS NO EVIDENCE OF ADDITIONAL MOISTURE INSIDE THE 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.

    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 A POWER (BATTERY LIFE W/ MOISTURE) 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
    672194 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR