BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1211544 · Received October 22, 2008

    Report

    Report Number
    2939301-2008-02750
    Event Type
    Injury
    Date Received
    October 22, 2008
    Date of Event
    October 18, 2008
    Report Date
    October 18, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 HER NEW ONETOUCH ULTRA2 METER WAS PROMPTING AN "ERROR 2" MESSAGE. PER THE ONE TOUCH ULTRA2 OWNER'S BOOKLET, THIS MESSAGE COULD BE CAUSED EITHER BY A USED TEST STRIP OR A PROBLEM WITH THE METER. THE MEDICAL AFFAIRS SPECIALIST (MAS) SPOKE WITH THE PT ON TWO DAYS LATER, AND OBTAINED THE FOLLOWING INFO. THE PT REPORTED THAT THE ALLEGED ISSUE BEGAN ON THE MORNING OF THE ORIGINAL DATE, WHEN SHE RECEIVED THE NEW METER. PRIOR TO OBTAINING THE SUBJECT METER, THE PT HAD REPORTED OBTAINING THE SAME ERROR MESSAGE ON TWO OTHER LFS METERS. AT 1:20 PM, AFTER ATTEMPTING TO USE THE NEW METER, THE PT STATED THAT HER BLOOD GLUCOSE DROPPED BECAUSE SHE BEGAN TO FEEL SHAKY, SWEATY, AND FELT VERY NAUSEOUS. AS A RESULT OF THE SYMPTOMS, THE PT CLAIMED SHE DRANK SOME ORANGE JUICE AND RESTED AND EVENTUALLY FELT BETTER. PRIOR TO WHEN THE ERROR MESSAGE BEGAN TO APPEAR ON HER LFS METERS, SHE USED TO TEST TWICE A DAY (MORNING AND NIGHT). IT IS UNCLEAR HOW LOW THE PT HAS BEEN UNABLE TO TEST ON HER LFS METERS. THE PT REPORTED TO THE MAS THAT SHE HAS BEEN UNABLE TO TEST SINCE FOUR MONTHS EARLIER; HOWEVER, WHEN REVIEWING THE PT'S HISTORY IT WAS NOTED THAT SHE FIRST BEGAN TO OBTAIN THE "ERROR 2" MESSAGE ON A PREVIOUS METER ON THE MONTH PRIOR TO ORIGINAL DATE. DESPITE NOT BEING ABLE TO TEST, THE PT REPORTED SHE HAS CONTINUED TO TAKE HER USUAL DOSE OF DIABETES MEDICATION (500MG OF METFORMIN 2X/DAY). AT THE TIME OF TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE CONFIRMED THE ALLEGED ERROR APPEARED WHEN A TEST STRIP WAS INSERTED. THE ISSUE REMAINED UNRESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT CLAIMS SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY 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 2857938

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening| R