BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2960353 · Received February 6, 2013

    Report

    Report Number
    2183996-2013-00158
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    January 26, 2013
    Report Date
    February 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
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, PATIENT REPORTED WAS HOSPITALIZED FOR A NON-DIABETES RELATED EVENT AND SHE EXPERIENCED SEVERE HYPOGLYCEMIA WHEN SHE ATTEMPTED TO RESUME INFUSION DEVICE THERAPY. HER NURSE TESTED HER BLOOD GLUCOSE, AND IT WAS 34 MG/DL. SHE WOKE THE PATIENT UP AND HAD HER DRINK JUICE. PATIENT REPORTED, SHE WOULD NOT HAVE BEEN ABLE TO SELF-TREAT HYPOGLYCEMIA HAD THE NURSE NOT WOKEN HER. PATIENT DID NOT WISH TO TROUBLESHOOT THE ISSUE AND SAID SHE WILL RESUME INFUSION DEVICE THERAPY WHEN SHE FEELS BETTER. SHE BELIEVES HYPOGLYCEMIA WAS CAUSED BY MEDICATION SHE RECEIVED AT THE HOSPITAL AND LACK OF APPETITE. NO ALLEGATIONS WERE MADE AGAINST THE INFUSION DEVICE OR RELATED SUPPLIES. NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49440 ACCU-CHEK SPIRIT LZG ROCHE HEALTH SOLUTIONS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention INSULIN| INSULIN INFUSION PUMP| RELATED ACCESSORIES