BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2072283 · Received April 28, 2011

    Report

    Report Number
    2531779-2011-02981
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    March 31, 2011
    Report Date
    March 31, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(6) 2011 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: DURING EVALUATION, THE PUMP BOOTED WITH A BLANK SCREEN AND A SOFTWARE ALARM OCCURRED. A REVIEW OF THE ALARM HISTORY VERIFIED PUMP SOFTWARE ALARMS HAD OCCURRED ON (B)(6) 2011. THE PUMP'S SOFTWARE FILES WERE RELOADED, AND THE PUMP WAS THEN EXERCISED FOR 24 HOURS WITH NO ALARMS AND NO ISSUES. EVALUATION DETERMINED THAT THE PUMP'S SOFTWARE WAS CORRUPTED.

    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.

    Description of Event or Problem · 1

    THE REPORTER REPORTED THE PATIENT'S PUMP WAS NOT POWERING ON, THE DISPLAY SCREEN WAS BLANK AND THE KEYPAD BUTTONS WERE UNRESPONSIVE. THE BATTERY CAP WAS INTACT AND SECURE. DURING TROUBLESHOOTING THE PATIENT THEN RECEIVED A LOW BATTERY ALARM FROM THE PUMP. THE PATIENT REPLACED THE PUMP BATTERY AND THIS RESOLVED THE ISSUE. 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 37 YR