BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4942971 · Received July 27, 2015

    Report

    Report Number
    2531779-2015-25605
    Event Type
    Malfunction
    Date Received
    July 27, 2015
    Report Date
    July 10, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 09/04/2015 - DEVICE EVALUATION: THE METER HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2015 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 THE ERROR 1 ALARM SUB CODE 5 MESSAGE.

    Additional Manufacturer Narrative · 1

    THE DEVICE 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) 2015, THE REPORTER CONTACTED ANIMAS, ALLEGING A METER ERROR (ERROR 1) ISSUE. IT WAS REPORTED THAT THE METER REMOTE EMITTED AN ERROR 1 MESSAGE THAT WOULD NOT CLEAR. 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
    486420 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR