BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1983262 · Received February 2, 2011

    Report

    Report Number
    2531779-2011-00639
    Event Type
    Malfunction
    Date Received
    February 2, 2011
    Report Date
    January 6, 2011
    Manufacturer
    ANIMAS CORP
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS AND EVALUATED. THE REPLACED BATTERY ALARMS OBSERVED IN BLACK BOX WERE REPORTEDLY DUE TO NORMAL BATTERY WEAR. THE BLACK BOX REVEALED THAT THE PUMP WAS RETURNING TO DEFAULT TIME AND DATE. THE REPORTED BATTERY WAS NOT RETURNED WITH THE PUMP FOR INVESTIGATION. THE BATTERY COMPARTMENT AND CAP WERE INTACT WITH NO PHYSICAL DAMAGE OR EVIDENCE OF MOISTURE INGRESS OBSERVED. THE PUMP POWERED ON NORMALLY AND WAS EXERCISED FOR 3 HOURS. NO OVERHEATING OR ALARMS WERE DUPLICATED. PUMP ELECTRICAL CURRENT DRAWS WERE TESTED AND FOUND TO BE WITHIN SPEC. AFTER SETTING THE DATE AND TIME ON PUMP, THE BATTERY WAS REMOVED. THE PUMP WAS LEFT WITHOUT POWER FOR 5 MINS. WHEN THE PUMP WAS POWERED ON, IT HAD RETURNED TO THE DEFAULT TIME AND DATE. THE PUMP COVER WAS REMOVED TO INSPECT FOR INTERNAL MOISTURE INGRESS AND NONE WAS FOUND. THE POWER FLEX, BATTERY CONNECTIONS AND INTERNAL COMPONENTS WERE TESTED FOR INTERMITTING CONDITIONS AND NO DEFECTS WERE FOUND. THE INTERNAL BATTERY (BT1) WAS FOUND TO HAVE FAILED. THE COMPLAINT REGARDING THE PUMP AND PUMP BATTERY OVERHEATING COULD NOT BE DUPLICATED DURING INVESTIGATION. THE ISSUE THAT THE PUMP SWITCHED TO DEFAULT DATE AND TIME AFTER A REBOOT IS UNLIKELY TO CAUSE AN ADVERSE EVENT. THE PUMP DISPLAYS THE "VERIFY" SCREEN AFTER IT IS REBOOTED AND THE TIME AND DATE MUST BE SET TO CONFIRM THE "VERIFY" SCREEN.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PT AND HIS MOTHER CONTACTED ANIMAS ALLEGING THAT THE PUMP AND PUMP BATTERY FELT HOT TO TOUCH. THEY DENIED THAT ANY INJURY RESULTED FROM THE ALLEGED ISSUE. BASED ON THE INFO PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGATION THAT THE PUMP AND PUMP BATTERY FELT HOT TO TOUCH. THERE IS NO EVIDENCE, HOWEVER, THAT THE ALLEGED ISSUE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PT DID NOT REPORT ANY HARM OR INJURY BECAUSE OF THE ALLEGED ISSUE.

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1