BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3211199 · Received July 8, 2013

    Report

    Report Number
    2531779-2013-09846
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Report Date
    June 10, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/04/2013 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE REWIND, LOAD CARTRIDGE, AND PRIME STEPS WERE PERFORMED SUCCESSFULLY WITH NO ALARMS. A FORCE SENSOR CALIBRATION TEST CONFIRMED THAT THE SENSOR WAS WITHIN REQUIRED SPECIFICATIONS. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO OCCLUSIONS OCCURRING. AN OCCLUSION WAS INDUCED AND THE PUMP GAVE THE APPROPRIATE VISUAL AND AUDIBLE "OCCLUSION DETECTED" ALARM. THE ISSUE OF THE ABSENCE OF OCCLUSION ALARMS WAS NOT DUPLICATED DURING THE INVESTIGATION. THERE WAS NO DEFECT FOUND. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A OCCLUSION (ABSENCE OF OCCLUSION ALARM) ISSUE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309629 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR