BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3123694 · Received May 22, 2013

    Report

    Report Number
    2531779-2013-06856
    Event Type
    Injury
    Date Received
    May 22, 2013
    Report Date
    April 25, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    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. 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

    (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP¿S HISTORY SHOWED THAT THE LAST BASAL DELIVERY WAS RECORDED ON (B)(4) 2013. NO ACTIVITY OUTSIDE OF NORMAL USE WAS OBSERVED IN THE HISTORY. THE BASAL HISTORY SHOWED A CHANGE IN THE BASAL RATE ON (B)(4) 2013 FROM 4 UNITS PER HOUR TO 3 UNITS PER HOUR. THE TOTAL DAILY DOSES ADDED UP TO CORRECTLY REFLECT THE USER¿S PROGRAMMED BASAL RATE. DURING TESTING, THE PUMP POWERED ON NORMALLY AND DISPLAYED THE VERIFY SCREEN. THE UNIT WAS TESTED FOR 24 HOURS WITH NO ERRORS OR ALARMS. THE FORCE SENSOR CALIBRATION WAS FOUND TO BE WITHIN SPECIFICATIONS. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. NO DELIVERY RELATED DEFECTS WERE FOUND DURING TESTING. THE KEYPAD BUTTONS WERE TESTED AND ALL RESPONDED PROPERLY. THE PUMP¿S COVER WAS OPENED AND NO DAMAGE WAS FOUND TO THE INTERNAL CIRCUIT BOARD.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT CONTACTED ANIMAS ALLEGING THAT SHE HAD BEEN EXPERIENCING LOW BLOOD GLUCOSE (BG) IN THE MORNINGS DOWN TO 46MG/DL WITH SWEATING AND CONFUSION. THE PATIENT REPORTEDLY TREATS LOW BG WITH JUICE AND FOOD. CUSTOMER TECHNICAL SUPPORT (CTS) REVIEWED THE PUMP WITH THE PATIENT AND FOUND ALL SETTINGS AND HISTORIES WERE CORRECT. CTS ADVISED THE PATIENT THAT THERE WAS NOTHING NOTED TO INDICATE THAT THE PUMP WAS OVER-DELIVERING, HOWEVER THE PATIENT STATED SHE HAD LOST CONFIDENCE IN THE PUMP. THE PUMP WAS REPLACED. THE PATIENT WAS ADVISED TO REVIEW BG MANAGEMENT WITH HER HEALTHCARE PROVIDER. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED HYPOGLYCEMIA WHILE USING INSULIN PUMP THERAPY WITH THE ALLEGATION OF A NON-SPECIFIC PUMP MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226094 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening