BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3191634 · Received June 26, 2013

    Report

    Report Number
    2531779-2013-09064
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    May 29, 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

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS TO REPORT HER BLOOD GLUCOSE READINGS RANGED FROM 62 MG/DL TO HI, ABOVE 600 MG/DL WHILE ON INSULIN PUMP THERAPY. HER BLOOD GLUCOSE READINGS HAVE BEEN HIGH SINCE FRIDAY. HE CHANGED HIS SITE/SET ON THE EVENING OF (B)(6) 2013. BY SATURDAY MORNING, HER BLOOD GLUCOSE WAS AT 400 MG/DL AND ¿HI¿ BY NOONTIME. AT THE TIME OF CONCERN, THE PATIENT WAS NOT FEELING GOOD AND HAD VERY DRY MOUTH, SLIGHT NAUSEA, BUT DENIED ANY KETONES. HE DOES NOT TAKE ANY INSULIN VIA SYRINGE. ON THE DAY OF THE CALL, THE PATIENT HAD BLOOD GLUCOSE READING OF 62 MG/DL IN THE AM TIME WHICH HE ADMINISTERED SELF TREATMENT WITH 3 GLUCOSE TABLETS. THE PATIENT¿S BLOOD GLUCOSE ELEVATED TO 400 MG/DL AND EVENTUALLY WENT DOWN TO 311 MG/DL. THERE WAS NO BENT OR KINKED CANNULA ISSUE. THE INFUSION SITE WAS NORMAL WITHOUT ANY BLEEDING OR KNOTS. THE INSULIN PUMP WAS DELIVERING AS PROGRAMMED. THERE WAS NO EVIDENCE OF A PRODUCT MALFUNCTION ASSOCIATED WITH THE PATIENT¿S BLOOD GLUCOSE EXCURSION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT HAD ELEVATED BLOOD GLUCOSE ABOVE 500 MG/DL WHILE ON INSULIN PUMP THERAPY. ALTHOUGH THERE WAS NO MALFUNCTION ASSOCIATED WITH THE REPORTED INCIDENT, THE ANIMAS PRODUCT COULD NOT BE RULED OUT AS A CONTRIBUTOR OF THE PATIENT¿S BLOOD GLUCOSE EXCURSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290067 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Life Threatening| R