BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3140219 · Received May 31, 2013

    Report

    Report Number
    2531779-2013-07440
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 7, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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. 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

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013 ALLEGING THE PATIENT EXPERIENCED LOW BLOOD GLUCOSE (BG) THAT MORNING OF 50 MG/DL WITH CONFUSION. THE REPORTER STATED THE PATIENT WENT TO BED THE PRIOR NIGHT WITHOUT CHECKING HER BG LEVEL AND THEN SLEPT STRAIGHT THROUGH FOR MORE THAN 10 HOURS. THE REPORTER STATED THE PATIENT WAS TREATED WITH CARBOHYDRATES AND BG RETURNED TO NORMAL AND PATIENT WAS DOING WELL AT THE TIME OF THE CALL. THE PUMP SETTINGS WERE CONFIRMED AS CORRECT BY THE REPORTER AND REVIEW OF THE PUMP DID NOT REVEAL ANY EVIDENCE OF DEFECT OR MALFUNCTION. THIS COMPLAINT IS BEING REPORTED BECAUSE ANIMAS CUSTOMER TECHNICAL SUPPORT DETERMINED THE PATIENT¿S LOW BG ISSUE WAS DUE TO IMPROPER DISEASE MANAGEMENT AND DID NOT INVOLVE PUMP MALFUNCTION OR DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242012 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Life Threatening| R