BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3955149 · Received July 24, 2014

    Report

    Report Number
    2531779-2014-21271
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Report Date
    July 15, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 09/18/2014 WITH THE FOLLOWING: A REVIEW OF THE PUMP¿S BLACK BOX HISTORY SHOWED NO ACTIVITY RELATED TO THE COMPLAINT WAS RECORDED. THE BATTERY COMPARTMENT AND BATTERY CAP ARE INTACT WITH NO PHYSICAL DAMAGE OR EVIDENCE OF MOISTURE DAMAGE OBSERVED. DURING TESTING, THE PUMP POWERED ON TO THE ¿VERIFY¿ SCREEN IN ACCORDANCE WITH NORMAL OPERATION. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO OVERHEATING OR ALARMS OCCURRING. THE PUMP¿S ELECTRICAL CURRENT DRAWS WERE FOUND TO BE WITHIN THE REQUIRED SPECIFICATIONS. THE PUMP CASE WAS REMOVED AND NO EVIDENCE OF INTERNAL MOISTURE DAMAGE WAS FOUND. THERE WERE NO DEFECTS FOUND TO THE POWER FLEX OR BATTERY CONNECTIONS. THE TEMPERATURE ISSUE WAS NOT ABLE TO BE DUPLICATED DURING INVESTIGATION. NO DEFECTS WERE FOUND. 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 TEMPERATURE (TEMP - NO PHYSICAL DAMAGE) 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
    434587 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR