BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® SPIRIT

    MDR report key: 3052073 · Received April 11, 2013

    Report

    Report Number
    2183996-2013-00641
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 31, 2013
    Report Date
    June 21, 2013
    Manufacturer
    ROCHE DIABETES CARE AG
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION THE COMPLAINT CANNOT BE VERIFIED DUE TO CARELESS HANDLING OF THE PRODUCT RESULT THE SOFT COMPONENTS OF THE HOUSING ARE WORN DOWN HEAVILY. THEREFORE MOISTURE MAY ENTER THE INSULIN PUMP AND DESTROY THE PUMP ELECTRONICS. THE PROBLEM MENTIONED BY THE CUSTOMER IS RELATED TO CARELESS HANDLING OF THE PRODUCT.

    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, THE PATIENT'S NURSE REPORTED THAT THE PATIENT WAS IN THE HOSPITAL AND HAD BEEN DIAGNOSED WITH DIABETIC KETOACIDOSIS ON (B)(6) 2013. THE PREVIOUS DAY THE PATIENT'S BLOOD GLUCOSE LEVEL WAS NORMAL AND RANGED FROM 112-187 MG/DL. THE NEXT MORNING SHE WOKE UP AND IT WAS ELEVATED AND RANGED FROM 483-600+ MG/DL BEFORE SHE WENT TO THE HOSPITAL. HER NORMAL BLOOD GLUCOSE RANGE IS 80-120 MG/DL. THE PATIENT WAS TREATED WITH AN IV OF INSULIN AT THE HOSPITAL. THE PATIENT DOES NOT ALLOW HER INSULIN TO REACH ROOM TEMPERATURE BEFORE USE. TROUBLESHOOTING WITH THE PATIENT DID NOT IDENTIFY ANY ISSUES WITH THE PERFORMANCE OF THE INFUSION DEVICE. THE PATIENT'S DOCTOR DID STATE THAT HE WANTED THE PATIENT'S INFUSION DEVICE REPLACED DUE TO GENERAL WEAR AND TEAR ON THE DEVICE. THE PATIENT STATED THAT SHE THINKS ONE OF THE INFUSION SETS MAY HAVE BEEN BLOCKED; THE PATIENT USES A COMPETITOR'S INFUSION SET. THE INFUSION DEVICE WAS REPLACED AND WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154560 ACCU-CHEK ® SPIRIT INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 062 YR Hospitalization| R SENTHROID| AVAPRO| NOVALOG| ASPIRIN| COREG| PLAVIX| INSET INFUSION SETS| SENSAPAR