BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3840004 · Received May 29, 2014

    Report

    Report Number
    2531779-2014-15207
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Report Date
    May 25, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 07/09/2014. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/30/2014 WITH THE FOLLOWING FINDINGS:A REVIEW OF THE PUMP BLACK BOX SHOWED THAT LOSS OF PRIME WARNINGS HAD OCCURRED. DURING TESTING, THE PUMP WAS EXERCISED FOR 24 HOURS WITHOUT LOSS OF PRIME WARNINGS BEING DUPLICATED. A FORCE SENSOR CALIBRATION TEST WAS PERFORMED AND FOUND THAT THE FORCE SENSOR READING WAS OUT OF SPECIFICATIONS. THE PUMP WAS OPENED AND NO INTERNAL FORCE SENSOR ISSUES WERE FOUND. DURING EVALUATION THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION BUT THE LOSS OF PRIME COMPLAINT WAS UNABLE TO BE DUPLICATED.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014 THE REPORTER CONTACTED ANIMAS ALLEGING THAT THE PUMP HAD EMITTED MULTIPLE LOSS OF PRIME WARNINGS ACROSS MULTIPLE DIFFERENT CARTRIDGES. 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
    316530 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR