BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® SPIRIT

    MDR report key: 2981203 · Received February 27, 2013

    Report

    Report Number
    2183996-2013-00261
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    February 4, 2013
    Report Date
    June 28, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. IT WAS UNKNOWN IF THE PATIENT USED ANY CONCOMITANT MEDICAL PRODUCTS.

    Additional Manufacturer Narrative · 1

    THE DELIVERY ACCURACY OF THE INSULIN PUMP WAS TESTED WITHIN THE PUMP DRIVE TEST ON THE DIAGNOSTIC TEST SYSTEM AND MEETS THE SPECIFICATIONS. THE ALARM FUNCTIONS OF THE INSULIN PUMP WERE TESTED WITHIN THE ALARM FUNCTION TEST ON THE DIAGNOSTIC TEST SYSTEM AND MEET THE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT REPORTED THAT SHE WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2013 AND DIAGNOSED WITH DIABETIC KETOACIDOSIS. HER BLOOD GLUCOSE LEVEL READ HI ON HER BLOOD GLUCOSE MONITOR AND AT THE HOSPITAL THEY TOLD HER IT WAS 619 MG/DL. HER NORMAL BLOOD GLUCOSE LEVEL IS UNDER 200 MG/DL. SHE WAS TREATED WITH AND IV OF INSULIN AT THE HOSPITAL AND RELEASED ON (B)(6) 2013. SHE STATED THAT THE CAUSE OF THE ELEVATED BLOOD GLUCOSE LEVEL WAS DUE TO RECEIVING E4 (OCCLUSION ERRORS) ON HER INFUSION DEVICE. THE INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83347 ACCU-CHEK ® SPIRIT INSULIN INFUSION PUMP LZG ROCHE HEALTH SOLUTIONS INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 059 YR Hospitalization| R