BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2071764 · Received April 28, 2011

    Report

    Report Number
    2531779-2011-02952
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Report Date
    March 30, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS. REVIEW OF THE PUMP HISTORY VERIFIED A BATTERY VOLTAGE DROP FROM 154VDC TO 138VDC ON (B)(4) 2011 AT 3:52PM. THE BATTERY RETURNED WITH THE PUMP SHOWS NO EVIDENCE OF OVERHEATING. THE BATTERY COMPARTMENT AND CAP ARE INTACT WITH NO PHYSICAL DAMAGE OR EVIDENCE OF MOISTURE INGRESS OBSERVED. THE PUMP POWERED ON NORMALLY AND WAS EXERCISED FOR 3 HOURS, WITH NO OVERHEATING OR ALARMS DUPLICATED. PUMP ELECTRICAL CURRENT DRAWS WERE TESTED AND FOUND TO BE WITHIN SPECIFICATIONS. THE POWER FLEX, BATTERY CONNECTIONS AND INTERNAL COMPONENTS WERE TESTED FOR INTERMITTING CONDITIONS WITH NO DEFECTS WERE FOUND. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT AT LEAST A MONTH PRIOR TO CONTACTING ANIMAS SHE NOTICED THAT HER PUMP WAS HOT AT THE BATTERY COMPARTMENT WHICH MADE THE ENTIRE PUMP FEEL WARM. SHE STATED IT WAS NOT WARM ENOUGH TO BURN HER. SHE REMOVED THE BATTERY TO LET THE PUMP COOL, PLACED ANOTHER BATTERY IN THE PUMP AND CONTINUED TO WEAR THE PUMP. SHE THOUGHT IT MAY HAVE BEEN BECAUSE SHE IGNORED THE "REPLACE BATTERY" ALARM. SHE STATED THAT ON THE EVENING SHE CALLED ANIMAS THE PUMP BECAME WARM AGAIN BUT NOT ENOUGH TO BURN HER. SHE DENIED ANY CORROSION OR MOISTURE IN THE BATTERY COMPARTMENT AND DENIES EXPOSURE TO WATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR