BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK TENDER INFUSION SET

    MDR report key: 1915653 · Received December 1, 2010

    Report

    Report Number
    2183996-2010-02537
    Event Type
    Injury
    Date Received
    December 1, 2010
    Date of Event
    November 6, 2010
    Report Date
    November 26, 2010
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FPA
    PMA / PMN Number
    K972135
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    ON (B)(6) 2010, PT REPORTED SHE HAS BEEN HOSPITALIZED AT LEAST TWICE FOR ELEVATED BLOOD GLUCOSE READINGS AND E4 (OCCLUSION) ERRORS. PT STATED SHE WAS HOSPITALIZED ON (B)(6) 2010 OR (B)(6) 2010; SHE COULD NOT RECALL THE DATE. PT REPORTED SHE HAD BEEN EXPERIENCING AN E4 (OCCLUSION) ERROR ON HER PRIMARY INFUSION DEVICE. PT STATED SHE CHANGED ALL OF THE ACCESSORIES, INCLUDING THE INFUSION ADAPTER, INSULIN CARTRIDGE AND THE INFUSION SET, BUT THE ERROR CONTINUED. PT REPORTED SHE SWITCHED TO HER BACKUP INFUSION DEVICE AND THE E4 (OCCLUSION) ERROR OCCURRED ON HER BACKUP INFUSION DEVICE ALSO. PT STATED SHE WAS DEHYDRATED, THIRSTY, VOMITING, SLUGGISH AND TIRED. PT REPORTED HER HUSBAND DROVE HER TO THE HOSPITAL AND THEY TREATED HER WITH AN IV OF INSULIN. PT STATED HER READINGS WERE ABOVE 500 MG/DL THAT DAY. PT'S TARGET BLOOD GLUCOSE RANGE IS AROUND 130 MG/DL. PT REPORTED THE INFUSION ADAPTER WAS CHANGED THE DAY OF THE HOSPITALIZATION IN AN ATTEMPT TO CLEAR THE E4 ERROR MESSAGE. PT STATED SHE CARRIES THE INFUSION DEVICE IN HER BRA. EXPLAINED THE MEANING OF AN E4 (OCCLUSION) ERROR. PT IS NOT CURRENTLY EXPERIENCING AN OCCLUSION. PT REPORTED SHE HAS ALREADY DISPOSED OF THE INFUSION SET. NO PRODUCT RETURN WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK TENDER INFUSION SET INSULIN INFUSION SET FPA ROCHE INSULIN DELIVERY SYSTEMS INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| O| R INSULIN| INSULIN INFUSION PUMP