BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® FLEXLINK INFUSION SET

    MDR report key: 3233645 · Received July 18, 2013

    Report

    Report Number
    2183996-2013-01317
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    April 1, 2013
    Report Date
    July 24, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS INC
    Product Code
    FPA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFORMATION CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. NO PRODUCT AVAILABLE TO BE RETURNED.

    Additional Manufacturer Narrative · 1

    SINCE NO MATERIAL HAS BEEN RETURNED FROM THE CUSTOMER AND NO LOT NUMBER IS KNOWN, NO INVESTIGATION COULD BE PERFORMED. THEREFORE, THE COMPLAINT CANNOT BE VERIFIED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVEL HAS BEEN OCCASIONALLY ELEVATED AS HIGH AS 400 MG/DL SINCE (B)(6) 2013. WHEN HE REMOVES THE INFUSION SET HE HAS FOUND THAT THE SOFT CANNULA IS KINKED. IN (B)(6) HE EXPERIENCED BLOOD GLUCOSE LEVELS HIGHER THAN 400 MG/DL, FELT SICK, THIRSTY, HEADACHE, AND STOMACH PAIN. HE DROVE HIMSELF TO THE HOSPITAL. THE PATIENT RECEIVED STATIONARY TREATMENT FOR 1.5 WEEKS. HE CORRECTED THE ELEVATED BLOOD GLUCOSE LEVELS VIA THE INFUSION DEVICE AND RECEIVED AND INFUSION OF FLUIDS. IN (B)(6), THE PATIENT EXPERIENCED THE SAME SYMPTOMS AND WENT TO THE HOSPITAL AND RECEIVED THE SAME TREATMENT; HE WAS IN THE HOSPITAL FOR 2 WEEKS FOR THIS INCIDENT. THE PATIENT DISCARDED THE USED INFUSION SETS; THEREFORE, NO PRODUCT IS AVAILABLE TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336001 ACCU-CHEK ® FLEXLINK INFUSION SET SUBCUTANEOUS INFUSION SET FPA ROCHE HEALTH SOLUTIONS INC 00700006959 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 048 YR Hospitalization| R NOVO RAPID