BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3180597 · Received June 20, 2013

    Report

    Report Number
    2531779-2013-08660
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Report Date
    May 23, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 08/06/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/15/2013 WITH THE FOLLOWING FINDINGS: ONE LOW BATTERY AND MULTIPLE REPLACE BATTERY ALARMS WERE OBSERVED IN THE BLACK BOX. THE KEYPAD WAS PEELING ALONG ENTIRE RIGHT SIDE AND SYMBOLS WERE WORN. ALL KEYS RESPONDED APPROPRIATELY. A BATTERY COMPARTMENT CRACK WAS OBSERVED IN THE THREAD AREA. THERE WAS NO EVIDENCE OF MOISTURE CONTAMINATION FOUND INSIDE BATTERY COMPARTMENT. THE CURRENT DRAWS WERE WITHIN SPECIFICATIONS. THE DISPLAY IS FADED, DISCOLORED AND DIFFICULT TO READ. THE FADED DISPLAY WAS REPLACED WITH TEST DISPLAY AND THE TEST SCREEN IS FULLY FUNCTIONAL AND IS FULLY ILLUMINATED WITH NO VISIBLE SIGNS OF FADING OR DISCOLORATION.

    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 THAT AFTER HE CHANGED CARTRIDGE TODAY PUMP SCREEN WENT BLANK. HE HAD CHANGED BATTERY ON (B)(6) 2013 BUT CHANGED BATTERY AGAIN , SCREEN CAME ON, WITH LIGHTS, BUT WOULD NOT ALLOW PUMP TO CHANGE SCREENS. HE REPLACED BATTERY FOR A SECOND TIME TODAY AND PUMP WAS ABLE TO MOVE FROM SCREEN TO SCREEN. HISTORY OF ALARMS SHOWS REPLACE BATTERY X 2. PATIENT REPORTS AUDIO BOLUS BUTTON MISSING AND PUMP WAS EXPOSURE TO MOISTURE YESTERDAY BUT HE CANNOT SEE ANY MOISTURE UNDER THE SCREEN OR IN BATTERY COMP. NO BG EXCURSIONS NOTED. CUSTOMER SUPPORT (CS) RECOMMENDED PATIENT DISCONTINUE PUMP THERAPY AND TO USE ALTERNATE METHOD OF INSULIN DELIVERY. 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
    279675 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR