BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1884414 · Received October 25, 2010

    Report

    Report Number
    2531779-2010-01845
    Event Type
    Injury
    Date Received
    October 25, 2010
    Date of Event
    September 21, 2010
    Report Date
    September 24, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(4) 2011 DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE TOTAL DAILY DOSE HISTORY FROM (B)(4) 2011 TO THE END OF PUMP USE ON (B)(4) 2011 INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THE DATA FOR THE BG EXCURSION REPORTED ON (B)(4) 2010 IS UNAVAILABLE FOR REVIEW DUE TO CONTINUED PUMP USE. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO INSULIN DELIVERY DEFECTS FOUND. THERE WERE NO DEFECTS FOUND ON INVESTIGATION. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT INADVERTENTLY DELIVERED A 25 UNIT BOLUS; THE PT STATED THAT "SHE THINKS SHE ACCIDENTLY PUSHED BUTTONS WHILE PLAYING AT THE SINK." AT THE TIME OF THE EVENT, THE PUMP WAS NOT LOCKED AND THE AUDIO BOLUS BUTTON WAS ENABLED TO DELIVER INSULIN AT THE RATE OF 1.0 UNITS PER BUTTON PRESS. THE SCHOOL NURSE REPORTED BLOOD GLUCOSE WAS 47 MG/DL SHORTLY AFTER THE PT REPORTED "FEELING LOW" AND SHE FED THE PT ORAL CARBOHYDRATES. A FAMILY MEMBER REPORTED THAT SHE TRANSPORTED THE PT TO THE HOSPITAL AND BLOOD GLUCOSE UPON ARRIVAL WAS ABOUT 40 MG/DL. THE PT WAS TREATED WITH INTRAVENOUS DEXTROSE, PLACED BACK ON THE PUMP FOR INSULIN DELIVERY, AND RELEASED ON THE SAME DAY. THE FAMILY MEMBER IS NOT ALLEGING ANY PUMP MALFUNCTION OR DEFECT; SHE STATED THAT THE PT IS WEARING THE PUMP WITHOUT FURTHER INCIDENT. IT WAS REPORTED THAT THE AUDIO BOLUS IS NO LONGER ENABLED AND THAT THE PUMP IS LOCKED AT ALL TIME OTHER THAN DURING BOLUS DELIVERY.

    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 10 YR