BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1944492 · Received December 23, 2010

    Report

    Report Number
    2531779-2010-02927
    Event Type
    Injury
    Date Received
    December 23, 2010
    Report Date
    November 16, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION HAS BEEN COMPLETED A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED TO ANIMAS THAT THE PUMP WAS NOT RECORDING THE BOLUS AMOUNT AND CANCELLED BOLUS AMOUNT IN THE PUMP'S HISTORY. SHE CLAIMED THAT HER BLOOD GLUCOSE RANGED FROM 244 TO OVER 500 MG/DL BUT DENIED SPILLING KETONES AND SHE REPORTEDLY DID NOT HAVE SYMPTOMS OF SHORTNESS OF BREATH, CRAMPS, OR CHEST PAIN. IT IS UNKNOWN HOW THE PATIENT TREATED HER ELEVATED BLOOD GLUCOSE LEVELS. THE PATIENT STATED THAT HER HBA1C WAS 6.0 AND NOW IT IS 9 POINT SOMETHING. THE PATIENT STATED THAT THE PUMP SETTINGS WERE CORRECT. THE ANIMAS REPRESENTATIVE HAD THE PATIENT GIVE AN AIR BOLUS AND IT WAS SUCCESSFUL AND IT RECORDED THE BOLUS IN THE PUMP'S HISTORY. THE PUMP WAS REPLACED EVEN THROUGH THE ANIMAS REPRESENTATIVE DID NOT FIND ANY INDICATION THAT THE PUMP WAS NOT WORKING PROPERLY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY DEVELOPED A BLOOD GLUCOSE LEVEL OVER 500 MG/DL AFTER THE REPORTED ISSUE BEGAN.

    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 Life Threatening