BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3233089 · Received July 18, 2013

    Report

    Report Number
    2531779-2013-11251
    Event Type
    Injury
    Date Received
    July 18, 2013
    Report Date
    June 20, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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

    ON (B)(6) 2013, THE LAY-USER/PATIENT CONTACTED ANIMAS TO REQUEST ASSISTANCE WITH CHANGING HER BASAL INSULIN REGIMEN BECAUSE HER AM BLOOD GLUCOSE READINGS HAVE BEEN LOW. HER AM READING HAVE BEEN IN THE 70 MG/DL RANGE AND WENT AS LOW AS 38 MG/DL ON (B)(6) 2013 AT 9-10 AM. DURING THE ALLEGED HYPOGLYCEMIC EVENTS, THE PATIENT REPORTEDLY WAS ABLE TO SELF TREATMENT WITH FOOD TO RESOLVE THE ISSUE. ON (B)(6) 2013, THE PATIENT HAD AN ELEVATED BLOOD GLUCOSE READING OF 383 MG/DL IN THE MIDDLE OF THE NIGHT. THE PATIENT CLAIMED SHE WAS ABLE TO TAKE BOLUS INSULIN TO LOWER HER BLOOD GLUCOSE TO 100 MG/DL. AT THE TIME OF CALL TO ANIMAS, THE PATIENT REMAINED ON INSULIN PUMP THERAPY. THE PATIENT WAS INSTRUCTED TO CALL HER HCP AND CONFIRMED WHAT THE BASAL SETTING SHOULD BE. THE PATIENT WILL CALL BACK FOR ASSISTANCE WITH THE CHANGES. THERE WAS NO PRODUCT MALFUNCTION ASSOCIATED WITH THE REPORTED EVENT. THE ADVANCE FEATURES AND THE BASAL SEGMENT ARE CORRECTLY PROGRAMMED ACCORDING TO THE PATIENT¿S USAGE. THE DATE AND TIME WAS CONFIRMED TO BE ACCURATE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT HAD LOW BLOOD GLUCOSE OF 38 MG/DL WHILE ON INSULIN PUMP THERAPY. ALTHOUGH THE PATIENT¿S HYPOGLYCEMIA TREND IN THE AM SUGGESTED THAT THE BASAL SEGMENT SETTING MAY NEED TO BE ADJUSTED, THE ANIMAS INSULIN PUMP COULD NOT BE RULED OUT AS A CONTRIBUTOR TO THE REPORTED INCIDENT. HENCE, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333402 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Life Threatening| R