BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4210774 · Received October 29, 2014

    Report

    Report Number
    2531779-2014-30790
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Report Date
    September 30, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/25/2014 WITH THE FOLLOWING FINDINGS: VISUAL INSPECTION REVEALED THAT THE BATTERY COMPARTMENT WAS CRACKED ABOVE AND BELOW THE GRIP PAD TO THE CASE SEAL. EVIDENCE OF MOISTURE WAS FOUND INSIDE THE BATTERY COMPARTMENT. THE RETURNED BATTERY CAP WAS NOT ABLE TO BE PROPERLY SECURED OR REMOVED FROM THE PUMP DUE TO THE TOP OF THE BATTERY CAP BEING WORN. THE PUMP WAS NOT ABLE TO BE POWERED ON DURING TESTING. A LEAK TEST WAS PERFORMED AND A BATTERY COMPARTMENT LEAK WAS FOUND. THE PUMP CASE WAS REMOVED AND NO EVIDENCE OF MOISTURE WAS FOUND 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (DAMAGED CAP W/MOISTURE) ISSUE. THE REPORTER ALLEGED THAT THERE WAS MOISTURE/CORROSION IN THE PUMP. IT WAS NOTED THAT THE BATTERY CAP THREADS WERE STRIPPED. 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
    693774 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR