BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2032311 · Received March 23, 2011

    Report

    Report Number
    2531779-2011-01822
    Event Type
    Injury
    Date Received
    March 23, 2011
    Date of Event
    February 20, 2011
    Report Date
    February 20, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6), 2011, THE LAY-USER/REPORTER CLAIMED THAT HER BLOOD GLUCOSE READING ELEVATED TO "400MG/DL" AFTER MULTIPLE OCCLUSION ALARMS PROMPTED BY THE ANIMAS PUMP. THE PT REPORTED SYMPTOMS OF "EXTREMELY THIRSTY, HAS NAUSEA AND DOESN'T FEEL WELL." NO KETONES WERE REPORTED AT THE TIME OF CONCERN. DURING TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE VERIFIED THERE WAS NO SIGN OF BENDING OR KINKING OF THE CANNULA. THE PT DID NOT ATTEMPT TO INJECT INSULIN WITH A SYRINGE. THE ANIMAS PUMP WAS DISCONNECTED FROM THE PT AS 3 SUCCESSFUL UNITS OF BOLUS WAS DISPENSED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSIONS: THE PT CLAIMED THAT HER BLOOD GLUCOSE WAS ELEVATED WITH SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA. ALTHOUGH THERE WERE MULTIPLE OCCLUSION ALARMS, THE PT HAS BEEN TRAINED TO GIVE HER "AN INJECTION OF INSULIN IF DELIVERY IS INTERRUPTED FOR ANY REASON."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Life Threatening| R