BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3032180 · Received April 3, 2013

    Report

    Report Number
    2531779-2013-03456
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 7, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    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.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2015 WITH THE FOLLOWING FINDINGS: UNABLE TO DUPLICATE THE COMPLAINT, THE PUMP INFORMATION FOR THE COMPLAINT DATE HAS BEEN OVERWRITTEN. THE BLACK BOX BEGINS ON (B)(6) 2015. DUE TO CONTINUOUS USE OF THE PUMP THE BLACK BOX DATA AND HISTORIES FOR THE EVENT HAVE BEEN OVERWRITTEN. AVAILABLE TDD¿S ADD UP CORRECTLY AND REFLECT THE USERS PROGRAMMED BASAL RATES. PUMP PASSED DELIVERY ACCURACY TEST AND WAS FOUND TO BE DELIVERING ACCURATELY AND WITHIN RANGE.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS REQUESTING ASSISTANCE WITH MAKING CHANGE TO REMINDERS IN THE PUMP . THE PATIENT REPORTS HER HEALTH CARE PROVIDER (HCP) WOULD LIKE TO HAVE HER BLOOD GLUCOSE (BG) CHECKED AT 0200-0300 AND 1 HOUR AFTER BOLUS. THE PATIENT REPORTS THIS IS NEEDED AFTER LOW BG OCCURRED (B)(6) 2013, DURING SLEEP. ALLEGEDLY, SHE WOKE UP IN THE MIDDLE OF THE NIGHT LAST NIGHT (B)(6) 2013 AND WAS SWEATY AND SHAKY, AND FELL WHEN GETTING UP. SHE REPORTS RECENT SEVERE HYPOGLYCEMIA. THE LOW BG WAS TREATED WITH MILK, BANANA AND TOAST WITH PEANUT BUTTER. HER BG WENT UP TO 350 MG/DL THEN DOWN TO 87 MG/DL IN LATER AM. THE PATIENT IS PREGNANT AND HAS GASTROPARESIS. SHE WAS SEEN BY HER HCP TODAY AND THE I:C WAS CHANGED. SHE HAD LOST WEIGHT. CUSTOMER TECHNICAL SUPPORT (CTS) ASSISTED THE PATIENT IN SETTING THE REMINDERS AND ADVISED HER TO CALL BACK IF FURTHER ASSISTANCE NEEDED. THERE IS NO INDICATION OF PUMP MALFUNCTION. THIS COMPLAINT IS BEING REPORTED DUE TO A PATIENT ON PUMP THERAPY EXPERIENCING HYPOGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137198 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Life Threatening