BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4251821 · Received November 14, 2014

    Report

    Report Number
    2531779-2014-32699
    Event Type
    Injury
    Date Received
    November 14, 2014
    Report Date
    October 27, 2014
    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. 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. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 02/03/2015 WITH THE FOLLOWING FINDINGS: BLACK BOX SHOWS EVIDENCE OF POWER INTERRUPTION ON (B)(6) 2014, RETURNED BATTERY CAP AND CARTRIDGE CAP WERE USED TO COMPLETE THE INVESTIGATION. CAP CONTACTS MEASUREMENTS ARE WITHIN SPECIFICATIONS. THE BATTERY COMPARTMENT AND THE BATTERY CAP ARE UNDAMAGED AND ABLE TO FIT SECURELY, THE BATTERY CAP WAS FASTENED AND THEN UNSCREWED ½ TURN WITH NO REBOOTS OCCURRING. NO POWER INTERRUPTION OR ANY EAW OCCURRED DURING THE INVESTIGATION. THE PRODUCT PERFORMS WITHIN SPECIFICATIONS. INVESTIGATORS WERE UNABLE TO DUPLICATE ¿INTERMITTENT POWER¿ COMPLAINT. THE PUMP¿S COVER WAS REMOVED, NO INTERMITTENT CONDITION WAS FOUND TO THE POWER PCB. 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) 2014, THE REPORTER CONTACTED ANIMAS ALLEGING INTERMITTENT POWER ON THE PUMP. THE REPORTER CONFIRMED THAT THERE WAS NO NOTED PHYSICAL DAMAGE TO THE BATTERY COMPARTMENT AND THERE WAS NO YELLOW O-RING VISIBLE AT THE TIME OF THE EVENT. 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
    736226 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR