BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 5785138 · Received July 12, 2016

    Report

    Report Number
    2531779-2016-15694
    Event Type
    Malfunction
    Date Received
    July 12, 2016
    Report Date
    June 22, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. 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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 09/22/2016 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/27/2016 WITH THE FOLLOWING FINDINGS:THE BATTERY COMPARTMENT IS CRACKED BELOW THE GRIP PAD, THE PUMP POWERS UP WITH AUDITORY AND VIBRATION TO A BLANK SCREEN. REPORTED ¿BLANK SCREEN¿ COMPLAINT IS DUPLICATED. THE PUMP¿S COVER WAS REMOVED, THE DISPLAY SCREEN WAS FOUND CRACKED. A TEST DISPLAY WAS MOUNTED, BUT THE PUMP STILL POWERS UP WITH AUDITORY AND VIBRATION TO A BLANK SCREEN. TEST CODE DOWNLOADER TOOL APPLICATION V 1.0.0 WAS USED TO UPLOAD TEST CODE V 1.1.12 TO MASTER/SLAVE/PERIPH PROCESSORS AS PER (6000975), THE UPLOAD WAS SUCCESSFUL. THE PUMP POWERS UP AND DISPLAY JUST ¿MSP¿ , NOT ¿MSP2¿, (2) IS THE EEPROM COMMUNICATING PROPERLY HENCE THE DIAGNOSIS THAT THE FAILURE IS IN THIS AREA. PCB INSPECTION FOUND LOWER EEPROM U22 CRACKED. EEPROM FAILURE IS CONCLUDED. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2016, 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
    441469 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR