BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2810289 · Received October 31, 2012

    Report

    Report Number
    2531779-2012-12970
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Report Date
    October 3, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED, AND IT WAS EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX DATA SHOWED THAT THE PUMP INFORMATION FROM THE REPORTED EVENT DATE HAD BEEN OVERWRITTEN. THE PUMP POWERED UP PROPERLY WITH THE RETURNED BATTERY CAP, WHICH WAS NOT ABLE TO COMPLETELY FASTEN TO THE PUMP DUE TO AN UNRELATED CASING-DAMAGE ISSUE. THE PUMP WAS EXERCISED FOR 24 HOURS; NO REBOOT, LOSS OF POWER, OR CALL SERVICE ALARMS WERE OBSERVED DURING THE EXERCISE PERIOD. A POWER LOSS EVENT WAS NOT OBSERVED DURING THE ANALYSIS; THE REPORTED EVENT WAS NOT DUPLICATED. MEASUREMENTS OF THE BATTERY CAP CONTACT WERE FOUND TO BE WITHIN THE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2012 THE REPORTER CONTACTED ANIMAS TO REPORT THE PUMP HAD INTERMITTENT POWER. THE TECHNICAL SUPPORT REPRESENTATIVE CONTACTED THE PATIENT TO OBTAIN INFORMATION AND TO TROUBLESHOOT THE PUMP; HOWEVER WAS UNABLE TO CONTACT HER BY TELEPHONE. NO TROUBLESHOOTING OF THE PUMP COULD BE PERFORMED. THERE WAS NO REPORT OF ANY PATIENT INJURY ASSOCIATED WITH THIS ISSUE. AS THE ISSUE WAS NOT RESOLVED, THIS COMPLAINT IS BEING REPORTED.

    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 22 YR