BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2921682 · Received January 11, 2013

    Report

    Report Number
    2183996-2012-02090
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 20, 2012
    Report Date
    June 11, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PISTON ROD OR THE ANTI-TWIST BUSHING OR THE ANTI-TWIST BUSHING CLIP OR DRIVE BUSHING ARE EXTREMELY CONTAMINATED AND CORRODED. THE PUMP HAS FUNCTIONAL DEFECTS DUE TO THE SEVERE CORRODED AND CONTAMINATED PISTON ROD. DUE THIS DEFECT THE PUMP CORRECTLY TRIGGERED THE E6 ERROR MESSAGE. THE SOFT COMPONENTS OF THE HOUSING ARE WORN DOWN HEAVILY. THEREFORE MOISTURE ENTERS THE INSULIN PUMP AND DESTROYS THE PUMP ELECTRONICS. THE PROBLEM MENTIONED BY THE CUSTOMER IS RELATED TO A CARELESS HANDLING OF THE PRODUCT.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT REPORTED THAT HER DOCTOR STATED THAT HER INFUSION DEVICE NEEDED TO BE REPLACED. ON (B)(6) 2012 IN THE EVENING HER BLOOD GLUCOSE LEVEL WAS 106 MG/DL AND SHE WENT TO BED. THE FOLLOWING MORNING HER BLOOD GLUCOSE LEVEL READ HI ON HER BLOOD GLUCOSE MONITOR. THE PATIENT TRIED TO CORRECT THE ELEVATED BLOOD GLUCOSE LEVEL WITH HER INFUSION DEVICE AND INJECTIONS, BUT IT DID NOT COME DOWN. SHE WENT TO THE HOSPITAL AROUND 3:00 PM ON (B)(6) 2012. HER NORMAL BLOOD GLUCOSE RANGE IS 110-120 MG/DL. THE PATIENT WAS TREATED WITH INJECTIONS OF INSULIN AT THE HOSPITAL. THE PATIENT'S DOCTOR STATED THAT THE INFUSION DEVICE WAS NOT DELIVERING INSULIN. SHE WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS. THE INFUSION DEVICE HAS NOT DISPLAYED ANY ERROR MESSAGES. TROUBLESHOOTING WITH THE PATIENT DID NOT IDENTIFY ANY PROBLEMS WITH THE INFUSION DEVICE. THE PATIENT THINKS THAT THE INFUSION DEVICE WAS NOT DELIVERING INSULIN ACCURATELY. THE INFUSION DEVICE, INFUSION SET, INSULIN CARTRIDGE, AND ADAPTER WERE REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18486 ACCU-CHEK SPIRIT LZG ROCHE HEALTH SOLUTIONS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R INSULIN| RELATED ACCESSORIES| INSULIN INFUSION PUMP| DATES OF THERAPY: UNK