BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4252451 · Received November 14, 2014

    Report

    Report Number
    2531779-2014-32756
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Report Date
    November 1, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 02/04/2015. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 01/19/2015 WITH THE FOLLOWING FINDINGS: THERE WAS NO UNEXPLAINED GAIN OR LOSS OF TIME OBSERVED IN THE PUMP'S BLACK BOX RECORDINGS. A MANUAL TIME AND DATE CHANGE WAS OBSERVED FROM 11/01/2014 AT 19:36 TO 11/02/2014 AT 07:41. NO ALARMS OR ERROR MESSAGES OCCURRED DURING THE INVESTIGATION. THE PUMP PASSED A TIME ACCURACY TEST AND WAS ABLE TO MAINTAIN THE CORRECT TIME AND DATE WITHOUT ANY ISSUES.

    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'S CLOCK WASN'T KEEPING TIME PROPERLY. 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
    738474 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR