BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4100358 · Received September 18, 2014

    Report

    Report Number
    2531779-2014-26723
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Report Date
    September 4, 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

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 01/21/2015-PRODUCT ANALYSIS:THE DEVICE WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 01/07/2014 WITH THE FOLLOWING FINDINGS:THE COMPLAINT WAS UNABLE TO BE DUPLICATED OR CONFIRMED WITH INVESTIGATION. REVIEW OF THE PUMP¿S BLACK BOX REVEALED EVIDENCE OF PARTIALLY DISCHARGED BATTERY INSTALLATION. A BATTERY COMPARTMENT CRACK WAS OBSERVED. THE RETURNED BATTERY CAP THREADS WERE FOUND TO BE DAMAGE; THE CAP WAS ABLE TO SECURE PROPERLY TO THE PUMP. THE PUMP¿S ELECTRIC POWER DRAWS WERE FOUND TO BE WITHIN SPECIFICATION. THERE WAS NO EVIDENCE OF DAMAGE OR DEFECT TO THE PUMP¿S INTERNAL COMPONENTS.

    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
    580653 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR