BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4212187 · Received October 29, 2014

    Report

    Report Number
    2531779-2014-30825
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Report Date
    October 15, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 03/18/2016 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2016 WITH THE FOLLOWING FINDINGS: THE PUMP'S BLACK BOX DATA FROM THE DATE OF THE ALLEGED ISSUE HAS BEEN OVERWRITTEN DUE TO CONTINUED USE OF THE PUMP. THE CURRENT BLACK BOX DATA SHOWS EVIDENCE OF CALL SERVICE 054 ALARMS ON (B)(6) 2016. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO ALARMS BEING DUPLICATED. THERE WAS NO EVIDENCE OF MOISTURE OR INTERMITTENT CONNECTION ON THE INTERNAL COMPONENTS OF THE PUMP.

    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 THERE WERE MULTIPLE CALL SERVICE 054 ALARMS WITH THE PUMP. 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
    692448 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR