BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3851997 · Received June 5, 2014

    Report

    Report Number
    2531779-2014-15923
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Report Date
    June 2, 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 07/21/2014. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/11/2014 WITH THE FOLLOWING FINDINGS:A REVIEW OF THE BLACK BOX AND PUMP HISTORY SHOWED NO EVIDENCE OF A BLANK DISPLAY SCREEN; HOWEVER, IT WAS FOUND THAT THE PUMP RECORDED A REPLACE BATTERY ALARM ON THE DATE OF THE COMPLAINT. THE PUMP WAS OFF FOR AN UNKNOWN PERIOD OF TIME AFTER THE ALARM EMITTED. THE PUMP¿S DISPLAY WAS FUNCTIONAL DURING TESTING. THE PUMP WAS OPENED AND THE PUMP AND DISPLAY WERE REMOVED FROM THE CASE, BUT NO DEFECTS WERE FOUND.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (BLANK SCREEN) ISSUE. 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
    328641 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR