BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3973454 · Received August 1, 2014

    Report

    Report Number
    2531779-2014-22091
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Report Date
    July 23, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 12/09/2015. DEVICE EVALUATION: THE PUMP WITH THE SERIAL NUMBER (B)(4) ASSOCIATED WITH THIS COMPLAINT WAS RETURNED AND INVESTIGATED ON 11/14/2014 IN RELATION TO ANOTHER COMPLAINT. PUMP (B)(4) WAS ADDED TO THIS COMPLAINT FILE ON (B)(6) 2015, AND THE FOLLOWING RESULTS OF PRODUCT ANALYSIS WERE OBTAINED FROM THE ORIGINAL INVESTIGATION: DURING A VISUAL INSPECTION OF THE PUMP, EVIDENCE OF MOISTURE INGRESS WAS FOUND IN THE BATTERY COMPARTMENT; THE COMPLAINT WAS DUPLICATED. A LEAK TEST WAS PERFORMED AND FAILED, INDICATING A LEAK AT THE BATTERY COMPARTMENT. THE PUMP CASE WAS REMOVED, AND NO FURTHER EVIDENCE OF MOISTURE INGRESS WAS FOUND. CORRECTION TO SUSPECT MEDICAL DEVICE SERIAL #.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (MOISTURE INGRESS) ISSUE. THE REPORTER ALLEGED THAT THERE WAS MOISTURE/CORROSION IN THE BATTERY COMPARTMENT. IT WAS NOTED THAT THERE WAS NO PHYSICAL DAMAGE TO THE PUMP. 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
    451031 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR