BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1040238 · Received May 7, 2008

    Report

    Report Number
    2939301-2008-00692
    Event Type
    Injury
    Date Received
    May 7, 2008
    Date of Event
    April 15, 2008
    Report Date
    April 16, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER, TEST STRIPS AND CONTROL SOLUTION FOR EVAL, BUT HAS NOT YET REC'D THEM. IF EITHER THE METER, STRIPS AND/OR CONTROL SOLUTION ARE RETURNED, LIFESCAN WILL EVAL 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 ALLEGING THAT A ONE TOUCH ULTRA 2 METER WAS TOO DIFFICULT TO USE. THE PT TESTS HER BLOOD GLUCOSE 4 OR MORE TIMES A DAY. SHE TAKES SELF-ADJUSTED INSULIN (UNK TYPE). THE PT INDICATED THAT THE ALLEGED ISSUE STARTED ON THE DAY BEFORE, AT AN UNK TIME. SHE DID NOT TAKE ANY ACTIONS RELATED TO DIABETES TREATMENT AS A RESULT OF THE ALLEGED ISSUE. AT AN UNSPECIFIED TIME AFTER THE ISSUE BEGAN, THE PT DEVELOPED SYMPTOMS OF SHAKINESS. HER BLOOD GLUCOSE WAS ALSO TESTED ON AN ER/HOSP METER AND A RESULT OF "53 MG/DL" WAS OBTAINED. IT IS NOT CLEAR AS TO WHEN THE PT WAS TESTED ON THE ER/HOSP METER. THE PT DENIED RECEIVING MEDICAL TREATMENT. IT WOULD HAVE BEEN HELPFUL TO KNOW THE FOLLOWING INFO: IF THE PT WAS ABLE TO TEST HER BLOOD GLUCOSE BEFORE AND AFTER THE SYMPTOMS DEVELOPED, WHEN THE RESULT OF "53 MG/DL" WAS OBTAINED, AND WHAT DATE/TIME THE SYMPTOMS STARTED. IN ADDITION, IT WOULD HAVE BEEN HELPFUL TO KNOW THE DETAILS OF THE PT'S DIABETES MANAGEMENT REGIMEN, WHAT ACTIONS THE PT TOOK BEFORE AND AFTER THE SYMPTOMS DEVELOPED, ADN WAT WAS DIFFICULT IN REGARDS TO USING THE METER. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PT CLAIMED THAT SHE DEVELOPED SYMPTOMS THAT CAN BE ASSOCIATED WITH SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN. IT IS NOT CLEAR IF THE PT WAS ABLE TO TEST WITH THE METER BEFORE DEVELOPING THE SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2766602

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Life Threatening