BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3895705 · Received June 25, 2014

    Report

    Report Number
    2531779-2014-18296
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Report Date
    June 23, 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

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1; DATE OF SUBMISSION: 08/11/2014 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED, AND IT WAS EVALUATED BY PRODUCT ANALYSIS ON 08/04/2014 WITH THE FOLLOWING FINDINGS:NO FINDINGS PERTINENT TO THIS COMPLAINT WERE OBSERVED IN THE HISTORY AND BLACK BOX DATA. THE BATTERY COMPARTMENT AND RETURNED BATTERY CAP WERE FOUND TO BE FREE OF DAMAGE, AND THE RETURNED BATTERY CAP FULLY TIGHTENED TO THE PUMP. NO POWER INTERRUPTIONS WERE OBSERVED DURING A 24HR EXERCISE PERIOD; THE INITIAL COMPLAINT OF A POWER ISSUE WAS NOT DUPLICATED. THE MEASUREMENTS OF THE RETURNED BATTERY CAP CONTACT WERE WITHIN SPECIFICATION. THE PUMP COVER WAS REMOVED AND NO EVIDENCE OF MOISTURE INGRESS OR DAMAGE TO THE POWER CIRCUIT WAS OBSERVED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (INTERMITTENT POWER) ISSUE. IT WAS REPORTED THAT THE PUMP INTERMITTENTLY LOST POWER. THE YELLOW O-RING OF THE BATTERY CAP WAS ALLEGEDLY VISIBLE WHILE THE CAP WAS ATTACHED TO 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
    371552 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR