BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2939301-1999-01086

    MDR report key: 257544 · Received December 29, 1999

    Report

    Report Number
    2939301-1999-01086
    Event Type
    Malfunction
    Date Received
    December 29, 1999
    Report Date
    December 3, 1999
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METER WAS NOT THE SUBJECT OF FDA RECALL Z-631-8

    Description of Event or Problem · 1

    THE REPORTER STATED THAT SHE DID BACK TO BACK BLOOD GLUCOSE TESTS, WITHIN 10 MINUTES, USING DIFFERENT FINGERSTICKS. HER RESULTS WERE 240, 200 AND 179 MG/DL. NO SYMPTOMS WERE REPORTED. ON FOLLOW-UP, THE REPORTER STATED THAT SHE CHECKS THE CONFIRMATION DOT FOR ENOUGH BLOOD; GETS GOOD SAMPLE OF BLOOD. SHE HAS A PROBLEM WITH A DAMAGED POWER BUTTON ON HER METER. HAVING OTHER HEALTH ISSUES SO DOESN'T KNOW IF HOW SHE FEELS IS FROM HER BLOOD SUGAR LEVEL OR FROM OTHER AILMENTS. THE LIFESCAN REPRESENTATIVE REVIEWED CODING, CLEANING, SAMPLE APPLICATION, AND USE OF CONTROL SOLUTION.

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other