BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1861924 · Received October 4, 2010

    Report

    Report Number
    2531779-2010-01447
    Event Type
    Injury
    Date Received
    October 4, 2010
    Report Date
    September 7, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVAL. IF THE DEVICE IS RETURNED, AN EVAL SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE SERIAL NUMBER FOR THIS DEVICE WAS ORIGINALLY REPORTED AS (B)(4). THE CORRECT SERIAL NUMBER FOR THIS DEVICE IS (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP WAS NO LONGER AVAILABLE FOR INVESTIGATION. THE INVESTIGATION WAS CLOSED ON (B)(4) 2012 DUE TO THE PUMP BEING UNABLE TO INVESTIGATE.

    Additional Manufacturer Narrative · 1

    ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP ON (B)(4) 2012 AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    Description of Event or Problem · 1

    THE PT'S BLOOD GLUCOSE LEVELS REPORTEDLY HAVE BEEN ELEVATED FOR THE LAST 2 WEEKS: HER BLOOD GLUCOSE LEVELS RANGED FROM 218-389 MG/DL MIDDLE OF THE NIGHT AROUND 2AM WHEN HER TARGET IS 150 MG/DL. THE PT CONTACTED ANIMAS BECAUSE SHE DISCOVERED THAT THE TIME FORMAT IN HER PUMP WAS INCORRECT: IT WAS SET TO AM INSTEAD OF PM, WHICH IMPACTED HER BASAL SETTINGS. THE ANIMAS REP WALKED THE PT THROUGH CORRECTING THE PUMP SETTINGS AND CONFIRMED THAT THE BASAL SETTINGS ARE NOW CORRECT. THE PT ALSO RECALLED HER BLOOD GLUCOSE READING "HIGH" ON HER METER ON AN UNK DATE. THE PARAMEDICS WERE CONTACTED BUT SHE WAS NOT TRANSPORTED TO THE HOSPITAL. THE PT WENT TO THE HOSPITAL THE FOLLOWING DAY TO GET "CHECKED OUT" THE PT WAS UNABLE TO PROVIDE ANY TIMES AND ADDITIONAL DETAILS OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORP. ONE TOUCH PING NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization