BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2132613 · Received June 17, 2011

    Report

    Report Number
    2531779-2011-04244
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 22, 2011
    Report Date
    May 22, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE PUMP POWERED ON PROPERLY. THE BOLUS BUTTON WAS FOUND TO BE MISSING. THE BUTTONS WERE FOUND TO BE UNRESPONSIVE TO PRESSES. THE KEYPAD WAS REMOVED AND NO DAMAGE WAS FOUND TO THE BUTTON CONTACTS. THE PUMP WAS OPENED AND CORROSION WAS FOUND INSIDE THE PUMP ON THE CIRCUIT BOARD. NO POWER ISSUES COULD BE DUPLICATED DURING INVESTIGATION. THE UNRESPONSIVE KEYPAD PREVENTED FURTHER INVESTIGATION OF THE PUMP.

    Description of Event or Problem · 1

    THE REPORTER, THE PATIENT'S FATHER, REPORTED POWER ISSUES WITH THE PUMP ON (B)(6) 2011. THE PATIENT OBTAINED A LOW BATTERY WARNING, AND REPLACED THE BATTERY TWICE. THE PUMP POWERED ON, HOWEVER, THE KEYPAD BUTTONS WERE UNRESPONSIVE. THERE WAS NO DAMAGE SEEN TO THE PUMP. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION OTP GLUCOSE MGMT SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR