BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® 3.15 ML INSULIN CARTRIDGE

    MDR report key: 3220848 · Received July 11, 2013

    Report

    Report Number
    2183996-2013-01251
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    June 24, 2013
    Report Date
    September 26, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS INC
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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. NO PRODUCT WAS RETURNED.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    ON (B)(6) 2013, A DIABETES SUPPORT SPECIALIST REPORTED THAT THE PATIENT WAS IN THE HOSPITAL WITH DIABETIC KETOACIDOSIS. THE REPORTER THINKS THE PATIENT IS NOT CORRECTLY PERFORMING INSULIN CARTRIDGE CHANGES AND NOT CONSISTENTLY PRIMING THE DEVICE. AIR BUBBLES WERE FOUND IN THE INSULIN CARTRIDGE AND THE INFUSION TUBING. THE PATIENT'S DOCTOR IS THINKING OF SWITCHING THE PATIENT TO MULTIPLE DAILY INJECTIONS OF INSULIN. THE PATIENT STATED THAT HER BLOOD GLUCOSE LEVEL WAS IN THE 400'S MG/DL ON (B)(6) 2013 AND SHE WAS UNABLE TO GET THE LEVEL TO COME DOWN. SHE WENT TO THE HOSPITAL AND WAS GIVEN AND IV OF INSULIN FOR TREATMENT. SHE WAS RELEASED THE NEXT DAY WHEN HER BLOOD GLUCOSE LEVEL RETURNED TO NORMAL. HER NORMAL LEVEL IS UNDER 230 MG/DL. THE INSULIN CARTRIDGE AND INFUSION SET WERE REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320160 ACCU-CHEK ® 3.15 ML INSULIN CARTRIDGE INSULIN INFUSION PUMP ACCESSORY LZG ROCHE HEALTH SOLUTIONS INC NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 031 YR Hospitalization| R NOVALOG