BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2851055 · Received November 29, 2012

    Report

    Report Number
    2531779-2012-14064
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Report Date
    November 2, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    FOLLOW-UP # 1 DATE OF SUBMISSION 09/16/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/19/2013 WITH THE FOLLOWING FINDINGS:A REVIEW OF THE PUMP¿S HISTORY SHOWED NO EVIDENCE OF TIME AND DATE ISSUES. DURING TESTING, THE PUMP POWERED ON NORMALLY WITH VIBRATORY ALERTS AND AUDIBLE SOUNDS. THE PUMP WAS TESTED FOR 24 HOURS WITH NO ERRORS, ALARMS, OR WARNINGS. A 10 UNIT NORMAL BOLUS AND A 10 UNIT AUDIO BOLUS WERE PERFORMED SUCCESSFULLY AND ACCURATELY RECORDED IN THE PUMP¿S HISTORY. THE EZMANAGER MAX 2.0.14 BOLUS DOWNLOAD CORRECTLY MATCHES THE IO SERVICE TOOL DOWNLOAD.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE REPORTER CONTACTED ANIMAS TO REPORT THERE WERE BOLUS DOSES GIVEN BUT NOT FOUND IN THE PUMP HISTORY. THE TECHNICAL SUPPORT REPRESENTATIVE CONTACTED THE PATIENT TO OBTAIN INFORMATION AND TO TROUBLESHOOT THE PUMP; HOWEVER WAS UNABLE TO REACH HIM BY TELEPHONE. THE ISSUE WAS NOT RESOLVED. THERE WAS NO PATIENT INJURY 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 18 YR