BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2046778 · Received March 31, 2011

    Report

    Report Number
    2531779-2011-02153
    Event Type
    Injury
    Date Received
    March 31, 2011
    Report Date
    March 3, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Removal / Correction Number
    2531779-02/25/11-001-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL CATALOG NUMBER: 100-124-01. THE CARTRIDGE WAS NOT RETURNED TO ANIMAS. ALTHOUGH THE CARTRIDGE WAS NOT RETURNED, THERE IS NO FURTHER INVESTIGATION NECESSARY WITH RESPECT TO THE LEAK ISSUE. CARTRIDGES WITH LOT # B201576 WERE CONFIRMED TO BE DEFECTIVE. WHEN TESTED, FLUID WAS OBSERVED LEAKING FROM THE PLUNGER END OF THE CARTRIDGE. A FAMILY MEMBER REPORTED THAT THE PT'S PHYSICIAN MADE ADDITIONAL ADJUSTMENTS TO THE PUMP SETTINGS. THE PT HAS CONTINUED TO USE THE PUMP WITH NO REPORTED SUBSEQUENT EVENTS. THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS 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 ELEVATED BLOOD GLUCOSE (BG ON METER READ HI); SHE HAD KETONES, NAUSEA, AND DIZZINESS. A FAMILY MEMBER STATED THAT THE PT WAS USING A CARTRIDGE WITH A RECALLED LOT NUMBER BUT SHE DID NOT NOTICE ANY LEAKAGE FROM THE CARTRIDGE OR IN THE CARTRIDGE COMPARTMENT. SHE NOTED THAT SHE WAS NOT PAYING ATTENTION TO THE CARTRIDGE AND THAT SHE REPLACED ONLY THE INFUSION SET AND INSULIN VIAL AT THE TIME OF THE BG EXCURSION. THE FAMILY MEMBER DENIED LEAKAGE OR BLOOD AT THE INFUSION SITE; A BENT OR KINKED CANNULA WAS NOT OBSERVED. SHE REPORTED THAT THE PT'S BG RESPONDED AND STAYED IN THE NORMAL RANGE OF 70 MG/DL TO 150 MG/DL. THE FAMILY MEMBER STATED THAT AROUND THE SAME TIME AS THIS EVENT THE PT'S HEALTH CARE PROVIDER WAS MAKING ADJUSTMENTS TO THE PUMP SETTINGS DUE TO GENERALLY ELEVATED BG (300 MG/DL) AFTER MEALS.

    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 B201576

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention