BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP

    MDR report key: 266782 · Received February 25, 2000

    Report

    Report Number
    2939301-2000-00115
    Event Type
    Malfunction
    Date Received
    February 25, 2000
    Report Date
    January 28, 2000
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CGA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATED THAT REPORTER'S SPOUSE'S BACK TO BACK (RAPID SUCCESSION) BLOOD GLUCOSE TESTS HAD RESULTS OF 16, 170, 133 AND 157 MG/DL. THE TESTS WERE DONE IN A FASTING STATE, USING DIFFERENT FINGER STICKS. REPORTER DID NOT HAVE ANY SYMPTOMS. THE TEST STRIPS USED DID NOT PASS A CONTROL SOLUTION TEST, 150 (HIGH OUT OF RANGE). USING NEW TEST STRIPS, THE 2ND CONTROL TEST WAS IN RANGE, 120 (91-131). THE REPORTER SAID THAT REPORTER'S SPOUSE'S METER HAD NEVER BEEN CLEANED, AND THAT REPORTER ASSISTS SPOUSE WITH ALL OF SPOUSE'S TESTING SINCE SPOUSE SUFFERED A STROKE. NO HARM WAS ALLEGED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other