BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2046789 · Received March 31, 2011

    Report

    Report Number
    2531779-2011-02146
    Event Type
    Injury
    Date Received
    March 31, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 3, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L CATALOG #: 100-124-01. THE PT REPORTED INSTANCES OF DIABETES MANAGEMENT AND CARE THAT INDICATE THAT THE BLOOD GLUCOSE (BG) EXCURSIONS COULD BE ATTRIBUTED IN PART TO USER ERROR. ROUTINE ADVICE FOR INSULIN PUMP USERS IS TO TEST BG AT LEAST FOUR TO SIX TIMES DAILY SO THAT CORRECTION INSULIN CAN BE DELIVERED TO PREVENT BG EXCURSIONS. INSULIN DRIPPING FROM THE INFUSION SITE INDICATES IMPROPER PLACEMENT OF THE CANNULA OR SCAR TISSUE AT THE SITE THAT IMPEDES INSULIN ABSORPTION. USER ERROR LIKELY CONTRIBUTED TO THE HYPERGLYCEMIA. THE PUMP AND CARTRIDGE HAVE NOT BEEN RETURNED TO ANIMAS. IF THE DEVICES ARE RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED BLOOD GLUCOSE (BG) OF 28MG/DL WITH DIZZINESS AND SHAKINESS FOLLOWED BY A BG READING OF >500MG/DL SEVERAL HOURS LATER. THE PT CONFIRMED THAT SHE DELIVERED A CORRECTION BOLUS AT THAT TIME AND THAT IT WAS THE ONLY BOLUS OF THE DAY. THE PT STATED THAT THE NEXT MORNING, HER BG WAS 45MG/DL WITH THE SAME SYMPTOMS. SHE REPORTED THAT SHE ATE AND BOLUSED SEVERAL TIMES; AT 12:12PM HER BG WAS 508MG/DL WITHOUT KETONES OR SYMPTOMS OF HYPERGLYCEMIA. MEDICAL INTERVENTION WAS NOT REQUIRED TO TREAT THESE BG EXCURSIONS. THE PT FOLLOWED ADVICE OF HER PHYSICIAN TO MANGE THE BG EXCURSIONS. SHE TESTS HER BG ONLY TWO TO THREE TIMES PER DAY. SHE SAID THAT THE PUMP SETTINGS WERE REVIEWED BY HER PHYSICIAN AND HE SAID THAT THEY WERE CORRECT. THERE WERE NO RELEVANT ALARMS IN THE PUMP HISTORY. THE PT OBSERVED THAT THE INSULIN DRIPPED OUT OF THE INFUSION SITE WHEN SHE REMOVED THE CANNULA. THE CANNULA WAS NOT BENT AND THERE WAS NO BLOOD IN THE CANNULA OR TUBING. THERE WAS NO EVIDENCE OF INSULIN LEAKAGE FROM THE SITE WHILE THE INFUSION SET WAS IN PLACE. SHE ROTATES THE INFUSION SITES APPROPRIATELY AND CHANGES THEM EVERY THREE DAYS. THE PT SAID THAT SHE OBSERVED VISIBLE MOISTURE IN THE COMPARTMENT THAT SMELLED LIKE INSULIN WHEN SER REMOVED THE CARTRIDGE. ACCORDING TO A FAMILY MEMBER, THE PT'S PHYSICIAN RECOMMENDED THAT THE PT DISCONTINUE INSULIN PUMP THERAPY DUE TO THE HYPERGLYCEMIA ALLEGED TO BE CAUSED BY THE PUMP AND/OR CARTRIDGES. THERE IS NO ALLEGATION AS TO THE CAUSE OF THE HYPOGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM INSULIN INFUSION PUMP AND CARTRIDGE LZG ANIMAS CORP. ONE TOUCH PING B201610

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention