BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4222239 · Received November 3, 2014

    Report

    Report Number
    2531779-2014-31312
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Report Date
    October 18, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER REMOTE 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.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE METER HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/21/2014 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION OF THE METER, SYSTEM/METER DATA CORRUPTION WAS FOUND. AN ERROR 1 SUB CODE 5 ALARM OCCURRED IMMEDIATELY WHEN POWERING ON THE METER. DURING TESTING, THE PUMP AND METER WERE NOT ABLE TO BE PAIRED AND THE REQUIRED INVESTIGATION WAS NOT ABLE TO BE PERFORMED DUE TO THE INABILITY TO CLEAR AN ERROR 1 ALARM SUB CODE 5 MESSAGE. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS METER REMOTE AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A METER ERROR (ERROR 1) ISSUE. THE REPORTER ALLEGED THAT THE METER REMOTE WAS EMITTING MULTIPLE ¿ERROR 1: SUB CODE SC5¿ MESSAGES RANDOMLY. IT WAS NOTED THAT THE ¿ERROR 1¿ MESSAGE WAS NOT ABLE TO BE CLEARED. 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
    702890 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR