BEUDAMED
    FDA Adverse Event Death Summary report: N

    SURESTEP

    MDR report key: 355593 · Received October 11, 2001

    Report

    Report Number
    2939301-2001-00659
    Event Type
    Death
    Date Received
    October 11, 2001
    Date of Event
    August 27, 2001
    Report Date
    September 12, 2001
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LIFESCAN RECEIVED A LETTER REPORTING THE DEATH OF A NURSING HOME PATIENT IN CONNECTION WITH THE USE OF A SURESTEP METER. THE PATIENT HAD AN UNKNOWN TERMINAL MEDICAL CONDITION. ON EVENT DATE, PATIENT HAD THEIR BLOOD GLUCOSE CHECKED SEVERAL TIMES ON THE SS METER BY THE NURSE ON DUTY. THE NURSE ON DUTY INTERPRETED THE SS METER RESULTS AS "1MMOL/L" AND PROCEEDED TO MANAGE THE PATIENT ACCORDINGLY. AS THE PATIENT'S CONDITION WORSENED, A GENERAL PRACTITIONER WHO WAS SUMMONED TREATED THE PATIENT ALSO FOR HYPOGLYCEMIA BASED ON THE NURSE'S REPORT. PATIENT'S CONDITION GRADUALLY DETERIORATED AND FINALLY DIED. IT WAS LATER FOUND THAT THE SS METER WAS ACTUALLY DISPLAYING "HI" AND NOT "1MMOL/L".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45872 SURESTEP BLOOD GLUCOSE MONITORING KIT/SYSTEM CFR LIFESCAN, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Death NO INFORMATION.