BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1222081 · Received November 4, 2008

    Report

    Report Number
    2939301-2008-02922
    Event Type
    Injury
    Date Received
    November 4, 2008
    Report Date
    October 17, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    LAY USER/PATIENT

    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/REPORTER CONTACTED LIFESCAN (LFS) ALLEGING THAT A ONE TOUCH ULTRA METER HAD A REVERTING TO THE SETUP MODE ISSUE. THE PATIENT TESTS HIS BLOOD GLUCOSE 3 TIMES A DAY. HE TESTS IN THE MORNING, AT NOON, AND IN THE EVENING. THE PATIENT TAKES 25 UNITS OF "HUMULIN" INSULIN IN THE MORNING AND 35 UNITS AT NIGHT. THE REPORTER MENTIONED THAT THE ALLEGED METER ISSUE STARTED "SEVERAL MONTHS AGO." SHE WAS UNABLE TO PROVIDE A SPECIFIC DATE/TIME. THE REPORTER CLAIMED THAT DUE TO THE METER ISSUE, THE PATIENT WAS UNABLE TO TEST HIS BLOOD GLUCOSE FOR A COUPLE OF MONTHS. DURING THAT TIME, THE PATIENT CONTINUED TO TAKE HIS INSULIN AS PRESCRIBED. ON AN UNSPECIFIED DATE/TIME AFTER THE ALLEGED METER ISSUE BEGAN, THE REPORTER CLAIMED THAT THE PATIENT DEVELOPED SYMPTOMS OF SHAKINESS, WEAKNESS, AND DIZZINESS. AS A RESULT OF THE SYMPTOMS, THE REPORTER CONTACTED THE PARAMEDICS WHO TESTED HIS BLOOD GLUCOSE WITH AN UNIDENTIFIED METER AND GOT A RESULT OF "40 MG/DL." THE PATIENT WAS TREATED WITH A "SUGAR CUBE" WHICH WAS PLACED UNDERNEATH HIS TONGUE. THE PARAMEDICS RETESTED HIS BLOOD GLUCOSE A SHORT TIME LATER AND GOT A "59 MG/DL." AT THAT POINT, THE PARAMEDICS TRANSPORTED THE PATIENT TO AN EMERGENCY ROOM (ER) WHERE HE RECEIVED A COUPLE OF SHOTS TO RAISE HIS BLOOD GLUCOSE. THE PATIENT WAS HOSPITALIZED FOR A FEW HOURS AND THEN DISCHARGED. THE REPORTER ADMITTED THAT THE ALLEGED METER ISSUE STARTED AFTER THE DEVICE'S BATTERY WAS REPLACED. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE REPORTER CLAIMED THAT THE PATIENT DEVELOPED SYMPTOMS OF SHAKINESS AND RECEIVED MEDICAL TREATMENT FOR SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN. THE REPORTER ALSO CLAIMED THAT THE PATIENT WAS UNABLE TO TEST HIS BLOOD GLUCOSE FOR A COUPLE OF MONTHS BECAUSE OF THE METER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2760901

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| L| R