BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1945272 · Received December 21, 2010

    Report

    Report Number
    2531779-2010-03109
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Report Date
    November 28, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 EVAL HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE PT'S MOM WAS ALLEGING THAT THE PUMP SUDDENLY LOST POWER "ONE HOUR AGO." SHE CLAIMED THERE WERE NO ALARMS, BUT BEEPED BEFORE SHUTTING DOWN. THE PT STATED THAT THE BATTERY CAP IS INTACT AND THERE ARE NO CRACKS ON THE PUMP. THE PUMP REGAINED POWER AFTER SHE REPLACED THE BATTERY AND AFTER SHE HAD HIT THE PUMP ON THE SIDE OF HER HAND. THE PUMP WAS REPLACED. THE PT'S BLOOD GLUCOSE REPORTEDLY WAS ELEVATED IN THE HIGH 300'S MG/DL, BUT WAS ASYMPTOMATIC AND WAS NEGATIVE FOR KETONES. THERE WERE NO REPORTS OF MEDICAL INTERVENTION. THE PUMP DID NOT CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT SINCE THE PT'S REPORTED INJURY IS NOT LIFE THREATENING. HOWEVER, THIS COMPLAINT IS BEING REPORTED DUE TO THE REPORTED POWER LOSS.

    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