BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1163082 · Received September 15, 2008

    Report

    Report Number
    2939301-2008-02257
    Event Type
    Injury
    Date Received
    September 15, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 10, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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 THE 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/PT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE ONETOUCH ULTRA2 METER HAD A "POWER ISSUE". THE MEDICAL AFFAIRS SPECIALIST (MAS) WAS ABLE TO CORRESPOND WITH THE PT BY TELEPHONE ON THE NEXT DAY, AND CLASSIFIED THE COMPLAINT BASED ON THE FOLLOWING INFO RECEIVED FROM THE CUSTOMER. THE PT TESTS HER BLOOD GLUCOSE 4 TIMES A DAY BEFORE MEALS AND BEFORE GOING TO BED. SHE MANAGES HER DIABETES VIA METFORMIN 1000MG TWICE DAILY AND VIA 70/30 NOVOLIN INSULIN 54 UNITS BEFORE BREAKFAST AND 53 UNITS BEFORE BED. THE PT STATED THAT THE REPORTED ISSUE BEGAN IN THE FIRST WEEK OF THE SAME MONTH PRIOR TO CONTACTING LFS. DURING THAT TIME, THE PT REPORTEDLY FOUND OUT THAT THE SUBJECT METER "WOULD NOT TURN ON". THE PT HAD THE SUBJECT METER FOR COUPLE OF YEARS. AT AN UNSPECIFIED TIME, AFTER THE REPORTED ISSUE, THE PT REPORTEDLY EXPERIENCED SYMPTOMS OF "FAINTING, SHORTNESS OF BREATH, SHAKINESS AND PERSPIRATION." THE PT STATED THAT THESE WERE TYPICAL OF "LOW BLOOD SUGAR SYMPTOMS" FOR HER. THE PT ALSO STATED THAT HER NURSE GETS ALL THE READINGS FROM THE SUBJECT METER FOR A WEEK AND MAKE CHANGES TO THE MEDICATIONS ACCORDINGLY. THEREFORE, DUE TO THE REPORTED ISSUE, THE PT REPORTEDLY DID NOT MAKE ANY CHANGES TO HER DIABETIC MEDICATIONS. THE PT REPORTEDLY TOOK "SUGAR" FOLLOWING THE REPORTED SYMPTOMS AND REPORTEDLY FELT BETTER. THE PT REPORTEDLY DID NOT RECEIVE/REQUIRE ANY OTHER MEDICAL TREATMENT FOR THE DIABETES. THE PT WAS NOT TESTED ON ANY OTHER METER. AT THE TIME OF TROUBLESHOOTING, IT WAS VERIFIED THAT THIS WAS NOT A NEW PRODUCT. THE PT WAS USING THE CORRECT TEST STRIPS AND HAD REPLACED THE BATTERY PER THE OWNER'S MANUAL. THE BATTERY WAS CHECKED AND FOUND OUT THAT IT WAS NOT CORRECTLY INSTALLED. IT WAS NOTED THAT THE METER WOULD NOT TURN ON AFTER INSTALLING THE BATTERIES CORRECTLY. HOWEVER, THE ISSUE WAS NOT RESOLVED WHEN THE POWER BUTTON WAS PRESSED OR WHEN THE TEST STRIP WAS INSERTED ALL THE WAY INTO THE TEST STRIP PORT. THE PT'S PRODUCTS ARE BEING REPLACED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THE PT CLAIMED THAT SHE DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2850183

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Life Threatening