BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1211571 · Received October 22, 2008

    Report

    Report Number
    2939301-2008-02740
    Event Type
    Injury
    Date Received
    October 22, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 13, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVALUATION, BUT HAS NOT YET RECEIVED THEM. IF EITHER THE METER OR STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE IT/THEM AND, IF EITHER METER OR STRIPS DO NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IN 2008, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE ONE TOUCH ULTRA METER HAD A BATTERY INDICATOR ISSUE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CONVERSATION THE CUSTOMER CARE ADVOCATE (CCA) HAD WITH THE PATIENT. THE PATIENT TESTS HER BLOOD GLUCOSE 4 TIMES A DAY AND SHE MANAGES HER DIABETES VIA GLIPIZIDE 2.5MG TWICE DAILY AND NOVOLIN N INSULIN TWICE DAILY, 25 UNITS AND 20 UNITS EACH. THE PATIENT STATED THAT THE REPORTED ISSUE FIRST BEGAN ON A WEEK EARLIER IN THE MORNING. DURING THAT TIME, THE PATIENT REPORTEDLY NOTICED "PLUS AND MINUS SIGNS" ON THE SUBJECT METER AND WHEN "SHE INSERTS THE TEST STRIP IN THE METER, THE METER WENT BLANK." THE PATIENT REPORTEDLY COULD NOT TEST ON THE SUBJECT METER, DUE TO THE REPORTED ISSUE AND DID NOT HAVE A BACK UP METER. FOLLOWING THE REPORTED ISSUE, THE PATIENT REPORTEDLY TOOK HER USUAL DOSE OF DIABETIC MEDICATIONS. AT AN UNSPECIFIED TIME (DATE AND TIME NOT KNOWN), AFTER THE REPORTED ISSUE, THE PATIENT REPORTEDLY EXPERIENCED SYMPTOMS OF "THIRSTINESS AND SHAKINESS", WHICH ACCORDING TO THE PATIENT WERE SYMPTOMS OF "LOW AS WELL AS HIGH BLOOD SUGAR." THE PATIENT WAS NOT TESTED ON ANY OTHER METER. THE PATIENT REPORTEDLY DID NOT RECEIVE/ REQUIRE ANY MEDICAL TREATMENT FOR THE DIABETES. DURING THE TROUBLESHOOTING,THE CCA NOTED THAT THIS WAS NOT A NEW PRODUCT AND THE CUSTOMER NEVER REPLACED THE BATTERIES PER THE OWNER'S MANUAL. THE PATIENT'S METER WAS REPLACED. BASED ON THE PROVIDED INFORMATION, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY DEVELOPED SYMPTOMS THAT CAN BE ASSOCIATED WITH HYPERGLYCEMIA AND HYPOGLYCEMIA, AFTER SHE COULD NOT TEST ON THE SUBJECT METER DUE TO THE BATTERY ISSUE. THERE IS NOT EVIDENCE THAT THE SUBJECT METER MALFUNCTIONED SINCE IT WAS NOT NOTED THAT THE PATIENT NEVER REPLACED THE BATTERIES (USE-ERROR) PER THE OWNER'S MANUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2771960

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Life Threatening