BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3200071 · Received July 1, 2013

    Report

    Report Number
    2531779-2013-09388
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Report Date
    June 6, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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) 2013, THE PATIENT CONTACTED ANIMAS AND STATED THE PUMP IS GIVING THE INCORRECT BLOOD GLUCOSE (BG) READINGS. THE PATIENT REPORTEDLY FELT DIFFERENT THAN WHAT THE READINGS INDICATED FROM THE PUMP. NO ADDITIONAL INFORMATION COULD BE OBTAINED FROM THE PATIENT AT THE TIME OF THE CALL. CUSTOMER SUPPORT (CS) HAS MADE MULTIPLE ATTEMPTS TO REACH THE PATIENT AND HAS BEEN UNSUCCESSFUL. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED DURING TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297639 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR