BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® SPIRIT

    MDR report key: 3011848 · Received March 19, 2013

    Report

    Report Number
    2183996-2013-00417
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    February 18, 2013
    Report Date
    April 15, 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
    IN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. PRODUCTION DATA WAS REVIEWED AND COMPLY WITH SPECIFICATIONS. THE ISSUE REPORTED BY THE PATIENT COULD NOT BE DUPLICATED. PRODUCT NOT RETURNED.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. (B)(4): NO PRODUCT HAS BEEN REQUESTED TO BE RETU.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT THE PATIENT HAD BEEN IN THE HOSPITAL ON (B)(6) 2013 WITH A BLOOD GLUCOSE LEVEL OVER 500 MG/DL. THE PATIENT'S NORMAL RANGE IS 100-130 MG/DL. BEFORE THE PATIENT WENT TO THE HOSPITAL HE WAS DIZZY, FELT SICK, AND COULDN'T GET UP. EMT'S ARRIVED AND TREATED HIM WITH AN IV OF ANTIBIOTICS TO TREAT HIS PNEUMONIA AND GAVE HIM INJECTIONS OF INSULIN. WHILE IN THE HOSPITAL THE PATIENT'S BLOOD GLUCOSE LEVELS NEVER DROPPED BELOW 200 MG/DL. ONCE HE RETURNED HOME, ON (B)(6) 2013, AND RESUMED USING THE INFUSION DEVICE HIS BLOOD GLUCOSE LEVELS RETURNED TO NORMAL. NO PRODUCT WAS REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113626 ACCU-CHEK ® SPIRIT INSULIN INFUSION PUMP LZG ROCHE HEALTH SOLUTIONS INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 086 YR Hospitalization| R