BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2042175 · Received March 28, 2011

    Report

    Report Number
    2531779-2011-02027
    Event Type
    Injury
    Date Received
    March 28, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 28, 2011
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO ANIMAS FOR EVAL. IF THE DEVICE IS RETURNED AN EVAL WILL BE CONDUCTED AND THE RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. IT WAS DETERMINED DURING TROUBLESHOOTING THAT THE PUMP SETTINGS WERE INCORRECT, WHICH MAY CONTRIBUTE TO THE PT'S LOW BLOOD GLUCOSE READINGS.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 SUBMITTED: (B)(4) 2012 . DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND WAS EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO DELIVERY ISSUES. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY.

    Description of Event or Problem · 1

    THE PT'S MOTHER ALLEGED THAT THE PT PROGRAMMED THE PUMP BY HERSELF AND HAD SEVERAL LOW BLOOD GLUCOSE LEVELS (AS LOW AS IN THE UPPER 30 MG/DL RANGE). SHE SAID THE PT TREATED HERSELF WITHOUT ANY ASSISTANCE. THE PT REPORTEDLY WAS NUMB AROUND HER MOUTH BUT DID NOT SUFFER ANY SEVERE SYMPTOMS. SHE THOUGHT THE AMOUNT OF INSULIN PROGRAMMED IS TOO HIGH AND THERE DOESN'T EVER APPEAR TO BE INSULIN ON BOARD (IOB). REVIEW OF THE PUMP SETTINGS REVEALED THAT THE PT'S NIGHTTIME BLOOD GLUCOSE TARGET WAS SET TO 100 +/- 10 MG/DL INSTEAD OF 120 +/- 10 MG/DL AND HAD PROGRAMMED HER INSULIN SENSITIVITY FACTOR TO 1 UNIT :6 MG/DL INSTEAD OF 1 UNIT:30 MG/DL. THE IOB DURATION WAS SET TO ONE HOUR. THE INCORRECT SETTINGS AS PROGRAMMED BY THE PT CAUSE OVER DELIVERY OF INSULIN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Life Threatening