BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1933807 · Received December 14, 2010

    Report

    Report Number
    2531779-2010-02846
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    November 13, 2010
    Report Date
    November 13, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. EVALUATION REVEALED MULTIPLE OCCLUSION ALARMS PRECEDED BY AN UNIDENTIFIED HIGH FORCE IN THE BLACK BOX WHICH COULD NOT BE DUPLICATED DURING TESTING. A FORCE SENSOR CALIBRATION TEST CONFIRMED THAT THE SENSOR IS DETECTING CORRECT FORCE. AN OCCLUSION WAS INDUCED AND THE PUMP GAVE APPROPRIATE VISUAL AND AUDIBLE ALERTS. NO INSULIN DELIVERY DEFECTS WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE READINGS WERE ABOUT 400MG/DL TO 500MG/DL FOR FOUR DAYS. ON (B)(6) 2010, SHE REPORTED THAT HER BLOOD GLUCOSE WAS 450MG/DL ACCOMPANIED BY NAUSEA, VOMITING, AND FEELINGS OF DEHYDRATION. THE PATIENT SAID THAT SHE DELIVERED INSULIN VIA INJECTION. SHE STATED THAT SHE WAS TAKEN BY A FAMILY MEMBER TO THE EMERGENCY ROOM WHERE SHE RECEIVED NO TREATMENT AS HER BLOOD GLUCOSE HAD RESOLVED TO 260MG/DL. THE PATIENT ALLEGED THAT THE PUMP WAS NOT DELIVERING BASAL INSULIN; SHE SAID THAT THE REMAINING INSULIN WAS 106 UNITS AND TWO HOURS LATER, IT WAS STILL READING 106 UNITS. SHE REPORTED, AND THE PUMP HISTORY CONFIRMED, THAT SHE EXPERIENCED TEN OCCLUSION ALARMS IN ONE WEEK. HER PRIOR REPORTS OF THE OCCLUSION ISSUE HAD BEEN PREVIOUSLY RESOLVED BY CUSTOMER SUPPORT WHO CONCLUDED THAT THEY WERE INFUSION SET AND SITE ISSUES. THE PATIENT REPORTED THAT SHE CHANGED HER INFUSION SET AND CARTRIDGE ONE TO TWO TIMES PER DAY; UPON REMOVAL ONE CANNULA WAS BENT, OTHERS HAVE BEEN STRAIGHT. SHE REPORTED THAT SHE IS USING CARTRIDGES FROM A NEW PACKAGE THAT IS NOT EXPIRED, SHE CYCLES CARTRIDGES APPROPRIATELY, AND THE INSULIN IS STORED CORRECTLY AND NOT EXPIRED. REVIEW OF INFUSION SET INSERTION TECHNIQUE IDENTIFIED NO ISSUES. THE PATIENT ROTATES SITES CORRECTLY; THERE IS NO REDNESS, IRRITATION, OR INFECTION NOTED AND NO AIR OR BLOOD IS SEEN IN THE TUBING OR CARTRIDGE. THE DELIVERY SPEED IS SET TO NORMAL AND OCCLUSION SENSITIVITY SETTING IS LOW. THE DATE AND TIME ARE CORRECTLY PROGRAMMED, THE BASAL RATE SETTINGS ARE ACCURATE, AND THE TOTAL DAILY DOSE IS CORRECT.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization