BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3190109 · Received June 26, 2013

    Report

    Report Number
    2531779-2013-09004
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Report Date
    May 28, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. DEVICE EVALUATION: REVIEW OF THE BLACK BOX DATA REVEALED MULTIPLE ¿POWER ON RESET¿ OR ¿REBOOT¿ CONDITIONS RECORDED ON (B)(6) 2013. ON EXAMINATION, THE BATTERY COMPARTMENT AS CRACKED FROM THE THREADS TO THE CASE SEAL. THE BATTERY CAP WAS NOT ABLE TO BE SECURED TO THE PUMP DUE TO THE CRACKED BATTERY COMPARTMENT, HOWEVER, LOSS OF POWER WAS NOT OBSERVED. THE BATTERY CAP WAS FOUND TO BE WITHIN SPECIFICATIONS. THE DISPLAY WAS NOTED TO BE FADED, DISCOLORED AND DIFFICULT TO READ. A TEST DISPLAY WAS ATTACHED TO THE PUMP AND ILLUMINATED PROPERLY AND WAS CLEARLY LEGIBLE. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO ISSUES. THE PUMP WAS OPENED FOR INVESTIGATION AND REVEALED NO EVIDENCE OF INTERNAL MOISTURE, DAMAGE OR DEFECT. INVESTIGATION WAS UNABLE TO DUPLICATE THE COMPLAINT.

    Additional Manufacturer Narrative · 1

    THE PUMP 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (INTERMITTENT POWER) ISSUE. THE PUMP IS REBOOTING ON HIM RANDOMLY. BATTERY CAP IS ABLE TO SECURE PER IFU. PATIENT DENIES ANY DAMAGE TO THE COMPARTMENT OR CAP. BATTERY CAP LAST CHANGED 2-3 WEEKS PRIOR TO 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
    290220 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR