BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRASMART METER

    MDR report key: 1163083 · Received September 15, 2008

    Report

    Report Number
    2939301-2008-02256
    Event Type
    Injury
    Date Received
    September 15, 2008
    Date of Event
    September 4, 2008
    Report Date
    September 9, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER, TEST STRIPS, AND CONTROL SOLUTION FOR EVALUATION, BUT HAS NOT YET RECEIVED THEM. IF EITHER THE METER, STRIPS AND/OR CONTROL SOLUTION ARE RETURNED, LIFESCAN WILL EVALUATE THEM AND, IF EITHER THE METER, STRIPS, OR CONTROL SOLUTION 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 A ONE TOUCH ULTRASMART METER WAS NOT WORKING. THE PT TESTS HER BLOOD GLUCOSE TWICE A DAY. SHE TAKES INSULIN (UNK TYPE/REGIMEN). THE PT INDICATED THAT THE ALLEGED METER ISSUE STARTED 2 WEEKS PRIOR TO CONTACTING LFS ON THE SAME DAY. THE PT SAID, "I WOULDN'T DO THE GLUCOSE" AND "IT WAS COMPLETELY OUT". SHE CLAIMED THAT SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE FOR 2 WEEKS. ON AN UNSPECIFIED DATE/TIME, THE PT MENTIONED THAT SHE CONTACTED HER DOCTOR BECAUSE SHE WAS "SICK". THE PT MENTIONED THAT SHE WAS "SCARED TO EAT". SHE ALSO CLAIMED THAT ON FIVE DAYS EARLIER, AN UNK PERSON CAME OVER TO TEST HER BLOOD GLUCOSE. THE PT STATED THAT HER BLOOD GLUCOSE WAS TESTED ON HER MOTHER'S METER AND A RESULT OF "60 MG/DL" WAS OBTAINED. THE PT CLAIMED THAT SHE WAS TREATED WITH "SUGAR" BECAUSE HER BLOOD GLUCOSE HAD "DROPPED TOO LOW." IT WOULD HAVE BEEN HELPFUL TO KNOW THE FOLLOWING INFO: IF THE PT WAS ABLE TO TEST HER BLOOD GLUCOSE WITH THE REPORTED METER DURING THE TIME OF CONCERN, WHAT SYMPTOMS, IF ANY, SHE HAD, AND WHAT ACTIONS THE PT TOOK IN RESPONSE TO THE ALLEGED METER ISSUE. IN ADDITION, IT WOULD HAVE BEEN HELPFUL TO KNOW WHAT DATE/TIME THE PT WAS TREATED WITH "SUGAR". WHILE SPEAKING TO THE ONE TOUCH CUSTOMER ADVOCATE (OTCA), THE PT WAS ABLE TO PERFORM A BLOOD GLUCOSE TEST WITH THE REPORTED METER. THE OTCA NOTED, HOWEVER, THE PT'S TEST STRIPS WERE EXPIRED. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PT CLAIMED THAT SHE WAS UNABLE TO TEST FOR 2 WEEKS BECAUSE OF THE ALLEGED METER ISSUE AND WAS TREATED WITH "SUGAR" BY AN UNIDENTIFIED PERSON. IT IS NOT CLEAR AS TO WHAT THE ACTUAL ALLEGED METER ISSUE WAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2521135

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Life Threatening| R