BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2960354 · Received February 6, 2013

    Report

    Report Number
    2183996-2013-00170
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    November 1, 2012
    Report Date
    January 25, 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
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE PRODUCT HAS NOT BEEN RETURNED FOR INVESTIGATION AND THE S/N IS NOT AVAILABLE, THE COMPLAINT COULD NOT BE REPRODUCED. NO PRODUCT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT IN (B)(6) 2012 THE PATIENT WENT TO THE HOSPITAL WITH LOW BLOOD GLUCOSE. THE PATIENT'S WIFE WAS UNABLE TO WAKE HIM THAT MORNING AND PARAMEDICS WERE CALLED AND THEY TOOK HIM TO THE HOSPITAL. THE PATIENT WAS TREATED FOR LOW BLOOD GLUCOSE AT THE HOSPITAL AND RELEASED WHEN HIS BLOOD GLUCOSE RETURNED TO NORMAL. HIS NORMAL RANGE IS IN THE 100'S MG/DL. THE PATIENT THINKS THE LOW BLOOD GLUCOSE WAS CAUSED BY USING THE INCORRECT TYPE OF INSULIN IN HIS INFUSION DEVICE. NO PRODUCT WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50231 ACCU-CHEK SPIRIT LZG ROCHE HEALTH SOLUTIONS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R INSULIN INFUSION PUMP| INSULIN| RELATED ACCESSORIES