BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3951843 · Received July 23, 2014

    Report

    Report Number
    2531779-2014-21045
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Report Date
    July 12, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 04/03/2015 ¿ DEVICE EVALUATION:THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 03/23/2015 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP¿S BLACK BOX HISTORY SHOWED THAT POWER REBOOTS HAD OCCURRED. THE BATTERY COMPARTMENT WAS FOUND TO BE INTACT; NO DAMAGE WAS OBSERVED. THE RETURNED BATTERY CAP WAS ABLE TO BE SECURED TO THE PUMP AND WAS ABLE TO MAINTAIN AN ELECTRICAL CONNECTION WITH THE PUMP. THE BATTERY CAP CONTACT HEIGHT AND WIDTH MEASUREMENTS WERE FOUND TO BE WITHIN THE REQUIRED SPECIFICATIONS. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO POWER REBOOTS OCCURRING. THE BATTERY CAP WAS UNSCREWED HALF A TURN WITH NO REBOOTS OCCURRING. THE PUMP CASE WAS REMOVED AND NO DAMAGE WAS FOUND TO THE POWER CIRCUIT. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THAT THE DISPLAY SCREEN WAS DIM AND DISCOLORED. THE COMPLAINT THAT THE PUMP WAS LOSING POWER INTERMITTENTLY WAS OBSERVED IN THE PUMP HISTORY BUT WAS NOT ABLE TO BE DUPLICATED DURING INVESTIGATION. 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

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (INTERMITTENT POWER) ISSUE. THE REPORTER ALLEGED THAT THE PUMP WAS LOSING POWER INTERMITTENTLY. IT WAS NOTED THAT A NEW BATTERY WAS INSERTED AND THE PUMP POWERED ON APPROPRIATELY. 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
    430376 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR