BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3073241 · Received April 23, 2013

    Report

    Report Number
    2531779-2013-04923
    Event Type
    Injury
    Date Received
    April 23, 2013
    Report Date
    March 27, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. 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 PATIENT CONTACTED ANIMAS FOR AN UNRELATED ISSUE AND DURING THE CALL MENTIONED THAT ON THE MORNING OF (B)(6) 2013, HE AWOKE WITH BLOOD GLUCOSE (BG) OF 40MG/DL WITH NO SYMPTOMS. THE PATIENT STATED THAT HE FELT FINE. THE PATIENT STATED HE DRANK JUICE AND HIS BG CAME UP. THE PATIENT REPORTED THAT HIS BGS ALWAYS GO LOWER OVERNIGHT AND DID NOT WISH TO REVIEW THE PUMP. THE PATIENT WAS ADVISED TO CONTACT HIS HEALTHCARE PROVIDER TO DISCUSS POSSIBLE SETTINGS ADJUSTMENTS DUE TO OVERNIGHT LOW BGS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY EXPERIENCED A LOW BG VALUE INDICATIVE OF A SERIOUS INJURY WHILE ON INSULIN PUMP THERAPY AND THE PUMP COULD NOT BE RULED OUT AS A CAUSE OR CONTRIBUTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173764 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Life Threatening