BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK TENDER INFUSION SET

    MDR report key: 1762344 · Received July 14, 2010

    Report

    Report Number
    2183996-2010-01418
    Event Type
    Injury
    Date Received
    July 14, 2010
    Date of Event
    June 12, 2010
    Report Date
    June 16, 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
    MD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B)(6)2010, PATIENT REPORTED BLOOD GLUCOSE HAS BEEN "AWFUL" OVER THE PAST FOUR DAYS. BLOOD GLUCOSE HAS ELEVATED TO RANGE OF 200-433 MG/DL. TARGET BLOOD GLUCOSE IS 150 MG/DL OR BELOW. PATIENT REPORTS HYPERGLYCEMIA WAS DUE TO INFUSION SITE LOCATION AND POSSIBLE SCAR TISSUE IN THAT AREA. PATIENT WENT TO ROUTINE DOCTOR'S APPOINTMENT ON (B)(6)2010. PATIENT REVIEWED ELEVATED READINGS WITH PHYSICIAN. PATIENT WAS SPILLING KETONES IN URINE AND WAS DIAGNOSED WITH DEHYDRATION AND A URINARY TRACT INFECTION. PATIENT WAS TREATED WITH SALINE DRIP AND THIS HELPED LOWER BLOOD GLUCOSE FROM 433 MG/DL TO 268 MG/DL. BLOOD GLUCOSE RETURNED TO TARGET RANGE AFTER INFUSION SITE WAS CHANGED ON THE MORNING OF (B)(6)2010. PATIENT WAS ADVISED ON MANUFACTURER RECOMMENDATIONS FOR INSULIN CARTRIDGE, INFUSION SET, AND ADAPTER. INFUSION DEVICE HAD NOT BEEN DROPPED OR EXPOSED TO WATER OR INSULIN INGRESS. TIME AND BASAL RATES SET CORRECTLY. NO ERROR MESSAGES WERE RECEIVED. PATIENT HAS NOTICED AIR BUBBLES IN INSULIN CARTRIDGE, WHICH WAS REPORTED IN SEPARATE COMPLAINT RECORD. NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    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 59 YR Required Intervention INFUSION DEVICE| INSULIN