BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1970319 · Received January 18, 2011

    Report

    Report Number
    2531779-2011-00315
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Report Date
    December 20, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. NO ACTIVITY RELATED TO THE COMPLAINT WAS OBSERVED IN THE BLACK BOX OR DOWNLOAD HISTORY. THE BLACK BOX DOWNLOAD VERIFIED A BATTERY VOLTAGE DROP FROM 161VDC ON (B)(6) 2010 AT 16:00 TO 138VDC ON (B)(6) 2010 AT 4:18. 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 8 HOURS. NO OVERHEATING OR ALARMS WERE DUPLICATED. PUMP ELECTRICAL CURRENT DRAWS WERE TESTED AND FOUND TO BE WITHIN SPECIFICATION. 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 COMPLAINT REGARDING PUMP AND BATTERY OVERHEATING COULD NOT BE DUPLICATED DURING INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PATIENT CONTACTED ANIMAS ALLEGING THAT THE PUMP WAS HOT TO TOUCH. THE PATIENT INDICATED THAT HE HAD THE PUMP FOR ONLY ABOUT 1-2 WEEKS. ON AN UNSPECIFIED DATE/TIME DURING THE TIME OF CONCERN, THE PATIENT CLAIMED THAT HE RECEIVED A LOW BATTERY ALARM. A FEW HOURS LATER, THE PATIENT CLAIMED THAT HE RECEIVED A REPLACE BATTERY ALARM. WHEN THE PATIENT PULLED THE PUMP OUT OF HIS POCKET TO REPLACE THE BATTERY, HE CLAIMED THAT THE PUMP WAS VERY HOT TO TOUCH. THE PATIENT DENIED THAT THE BATTERY WAS LEAKING OR THAT THERE WAS MOISTURE IN THE BATTERY COMPARTMENT. THE PATIENT CLAIMED THAT THE CAP WAS SECURE TO THE PUMP AND THE O-RING WAS NOT VISIBLE. THE PATIENT DENIED THAT HE GOT BURNED OR RECEIVED MEDICAL TREATMENT BECAUSE OF THE ALLEGED ISSUE. THE PATIENT WAS ADVISED TO FOLLOW A BACKUP PLAN. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGATION THAT THE PUMP OVERHEATED.

    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