BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1902518 · Received November 12, 2010

    Report

    Report Number
    2531779-2010-02247
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    October 8, 2010
    Report Date
    October 12, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. THE PUMP WAS EVALUATED AND FOUND TO BE DELIVERING INSULIN ACCURATELY. INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO ISSUES. A NORMAL 10 UNIT BOLUS WAS PROGRAMMED, DELIVERED, AND RECORDED IN THE HISTORY ACCURATELY. A TIME-KEEPING ACCURACY TEST WAS PERFORMED. THE PUMP WAS FOUND TO RETURN TO THE DEFAULT TIME AND DATE WHEN THE BATTERY WAS REMOVED AND REINSERTED. THE PUMP WAS NOT OBSERVED TO LOSE OR GAIN TIME OVER THE FIVE DAY TEST. INVESTIGATION REVEALED THAT THE INTERNAL BATTERY FAILED. A FAMILY MEMBER REPORTED THAT THE TIME AND DATE WERE NOT CORRECT AT THE TIME OF THE EVENT. AS THE PUMP DID NOT LOSE OR GAIN TIME, IT IS LIKELY THAT THE FAMILY MEMBER OR THE PT DID NOT ACCURATELY PROGRAM THE TIME AND DATE AND THAT THIS USER ERROR CAUSED OR CONTRIBUTED TO THE ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED BLOOD GLUCOSE OF 506 MG/DL WITHOUT KETONES; THE PATIENT WAS NAUSEATED BUT HAD NO OTHER SIGNS OR SYMPTOMS OF HYPERGLYCEMIA. SHE WAS TREATED WITH INSULIN DELIVERIES VIA THE PUMP AND SYRINGES; SHE RECEIVED INTRAVENOUS FLUIDS. THE PATIENT WAS DISCHARGED FOUR HOURS LATER WITH BLOOD GLUCOSE OF 180 MG/DL. A FAMILY MEMBER REPORTED THAT SHE CHANGED THE INFUSION SET SEVERAL TIMES PRIOR TO THE EMERGENCY ROOM VISIT. SHE DENIED CHANGES IN MEDICATION, DIET, OR EXERCISE. THE FAMILY MEMBER REPORTED THAT SHE CHANGES THE INFUSION SITE EVERY 1 1/2 DAYS, THE SITES APPEARED HEALTHY AND FREE OF SCAR TISSUE, AND THERE HAVE BEEN NO BENT OR KINKED CANNULAS. SHE DENIED ANY PROBLEMS WITH LEAKING OR AIR IN THE CARTRIDGE OR TUBING. THE INSULIN APPEARED NORMAL AND IS LESS THAN (B)(6). THE FAMILY MEMBER MENTIONED THAT THE TIME AND DATE ARE CURRENTLY INCORRECT. SHE REPORTED THAT THE TIME AND DATE WERE INCORRECT OFTEN OVER THE PAST SEVERAL WEEKS; SHE ATTRIBUTED THIS ISSUE TO THE PUMP TIME BEING SLOW AND THE DATE BEING OFF BY TWO DAYS. THE FAMILY MEMBER REPORTED THAT THE TIME AND DATE CHANGED TO THE DEFAULT SETTING WITH EVERY BATTERY REMOVAL. ON REVIEW OF THE ALARM AND TOTAL DAILY DOSE HISTORIES, THE FAMILY MEMBER SAID SHE WAS UNABLE TO RETRIEVE ACCURATE READINGS DUE TO THE TIME AND DATE ALTERATIONS.

    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 15 YR Hospitalization