BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2980889 · Received February 27, 2013

    Report

    Report Number
    2183996-2013-00248
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    February 1, 2003
    Report Date
    April 23, 2013
    Manufacturer
    ROCHE DIABETES CARE AG
    Product Code
    LZG
    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 COMPLAINT DESCRIBING BREAST CANCER DUE TO A ROCHE PRODUCT CANNOT BE VERIFIED. NO SAMPLE WAS RECEIVED FOR EVALUATION. ROCHE PUMPS ARE TESTED FOR ELECTROMAGNETIC COMPATIBILITY AND ARE SPECIFIED ACCORDING (B)(4). THEY COMPLY WITH THE RELEVANT MEDICAL STANDARDS REGARDING THE DESIGN VERIFICATION PROTOCOL ((B)(4)). THE TEXTILES ARE TESTED FOR BIOCOMPATIBILITY (TESTED FOR HARMFUL SUBSTANCES; OEKO-TEX STANDARD 100) AND COMPLY WITH THE RELEVANT STANDARD. THE PRODUCTS MEET THE STANDARD REGARDING THE RELEVANT CERTIFICATE ((B)(4)). DEVICE WAS NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THIS 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. WILL NOT BE RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    PATIENT REPORTED SHE WAS DIAGNOSED WITH BREAST CANCER 10 YEARS AGO. SHE SUSPECTS BREAST CANCER WAS CAUSED BY CARRYING THE INFUSION DEVICE NEAR HER LEFT BREAST. SHE HAD SURGERY IN 2006 AND IS CURRENTLY "CURED." SHE NOW CARRIES THE INFUSION DEVICE IN HER TROUSER POCKET. NO PRODUCT WILL BE RETURNED FOR EVALUATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84617 ACCU-CHEK SPIRIT INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG 00700006862 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other INSULIN