BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4093203 · Received September 16, 2014

    Report

    Report Number
    2531779-2014-26387
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Report Date
    August 29, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO ANIMAS. 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 10/09/2014. THE DEVICE HAS BEEN RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS AS FOLLOWS: THE TOP OF THE BATTERY CAP WAS OBSERVED TO BE DAMAGED. THE BATTERY CAP WAS ABLE TO FULLY TIGHTEN UNTIL THE O-RING WAS SEATED AND THE CAP WAS FLUSH WITH THE PUMP CASE; NO POWER REBOOTS OCCURRED. THE CAP COULD BE REMOVED WITH NO ISSUES AND THE BATTERY CAP THREADS WERE OBSERVED TO BE INTACT. THE BATTERY CAP SPRING WAS SECURE AND THE BATTERY CAP CONTACT HEIGHT AND WIDTH WERE WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS ALLEGING DAMAGE TO A BATTERY CAP. THIS COMPLAINT IS AGAINST THE BATTERY CAP ALONE. THE REPORTER STATED THAT THE BATTERY CAP WAS DAMAGED AND COULD NOT BE REMOVED FROM THE PUMP. REPORTEDLY, THE BATTERY CAP HAD BEEN CHANGED WITHIN 1 TO 3 MONTHS AND THERE WAS NO MOISTURE OR DAMAGE TO THE PUMP. THERE WAS NO INDICATION THAT THE PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE REMAINED UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573239 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR