BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRAMINI METER

    MDR report key: 1033903 · Received April 24, 2008

    Report

    Report Number
    2939301-2008-00617
    Event Type
    Injury
    Date Received
    April 24, 2008
    Report Date
    April 7, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 REPORTER/VISITING-NURSE CONTACTED LIFESCAN ALLEGING THAT A ONE TOUCH ULTRAMINI METER HAD AN "APPLY SAMPLE" ISSUE. THE MEDICAL AFFAIRS SPECIALIST (MAS) SPOKE TO THE PATIENT DIRECTLY ON APRIL 18, 2008, AND WAS ABLE TO OBTAIN/VERIFY INFORMATION. THE PATIENT TESTS HER BLOOD GLUCOSE THREE TIMES A DAY. SHE TAKES SLIDING-SCALE INSULIN (UNKNOWN TYPE) BASED ON HER METER READINGS. SHE ALSO TAKES UNIDENTIFIED PILLS FOR HER DIABETES. THE PATIENT WAS UNABLE TO PROVIDE DETAILS REGARDING HER MEDICATION REGIMEN. THE PATIENT STATED THAT SHE HAD THE METER FOR OVER A MONTH BUT THE DEVICE "NEVER WORKED". THE PATIENT MENTIONED THAT DURING THAT TIME, SHE WAS NEVER ABLE TO GET A METER READING. SHE DID NOT HAVE BACKUP METER FOR TESTING. AS A RESULT, THE PATIENT GUESSED ON HER INSULIN DOSAGES BUT CONTINUED TO TAKE HER MEDICATIONS AS PRESCRIBED. ON AN UNSPECIFIED DATE/TIME AFTER THE ALLEGED METER ISSUE BEGAN, THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS OF "EXTREME THIRST." THE NURSE DID NOT HAVE TEST STRIPS FOR TROUBLESHOOTING. THE METER AND TEST STRIPS WERE REPLACED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE REPORTER CLAIMED THAT THE PATIENT DEVELOPED SYMPTOMS THAT CAN BE ASSOCIATED WITH HYPERGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN. THE PATIENT WAS UNABLE TO TEST HER BLOOD GLUCOSE FOR OVER A MONTH BECAUSE OF THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2705556

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Life Threatening