BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1822826 · Received August 30, 2010

    Report

    Report Number
    2531779-2010-01130
    Event Type
    Injury
    Date Received
    August 30, 2010
    Date of Event
    July 25, 2010
    Report Date
    July 28, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PT REVIEWED PUMP SETTING AND HISTORY. SHE REPORTED THAT BASAL INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. BASAL DELIVERY ON (B)(6) 2010 WAS 81.2 UNITS AND BOLUS DELIVERY WAS 7.85 UNITS. ON (B)(6) 2010, BASAL DELIVERY WAS 80.87 UNITS AND BOLUS DELIVERY WAS 9.45 UNITS. BOLUS INSULIN WAS APPROXIMATELY 8%- 10% OF BASAL INSULIN FOR 2 DAYS PRIOR TO HOSPITALIZATION. THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVAL SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). DAILY INSULIN DELIVERY TOTALS WERE REVIEWED AND CORRECTLY REFLECT THE USERS PROGRAMMED BASAL RATES. NO ALARMS OR PUMP CONDITIONS INDICATING A MALFUNCTION WERE RECORDED IN BLACK BOX OR ALARM HISTORY. THE PUMP WAS TESTED ON A 29 HOUR FLOW TEST AND WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATION. UNRELATED TO THIS COMPLAINT, THE PUMP BOOTS TO THE VERIFY SCREEN WITH PINKISH CONTRAST FADED DISPLAY SCREEN. PUMP COVER REMOVED TO REPLACE SCREEN; PUMP BOOTED TO NORMAL CONTRAST WITH REPLACEMENT SCREEN.

    Description of Event or Problem · 1

    THE PT REPORTS HOSPITALIZATION FOR DKA WITH BLOOD GLUCOSE READING OF 560 MG/DL AT TIME OF ADMISSION.

    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 21 YR Hospitalization