BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRASMART METER

    MDR report key: 1033904 · Received April 24, 2008

    Report

    Report Number
    2939301-2008-00613
    Event Type
    Injury
    Date Received
    April 24, 2008
    Report Date
    April 4, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 PATIENT, WHO IS A PHYSICIAN, CONTACTED LIFESCAN ALLEGING THAT A ONE TOUCH ULTRASMART (OTUS) METER HAD AN "ERROR 5" ISSUE. THE PATIENT TESTS HIS BLOOD GLUCOSE 3 TIMES A DAY. HE TAKES 20 UNITS OF LEVEMIR TWICE A DAY. HE ALSO TAKES SLIDING-SCALE HUMALOG INSULIN TWICE A DAY BASED ON HIS METER READINGS AT MEAL TIMES. THE PATIENT ONLY EATS TWO MEALS A DAY. THE PATIENT WAS UNABLE TO INDICATE WHEN THE ALLEGED METER ISSUE BEGAN BUT SAID THAT IT HAD "BEEN SOME TIME". DURING THAT TIME, THE PATIENT WAS ABLE TO TEST ON AN UNIDENTIFIED BACKUP METER. HOWEVER, ON THE DAY BEFORE, THE PATIENT FORGOT HIS BACKUP METER AT WORK AND TRIED TO TEST WITH THE REPORTED OTUS METER DURING HIS EVENING MEAL, THE PATIENT REPORTEDLY WAS UNABLE TO TEST HIS BLOOD GLUCOSE BECAUSE OF THE "ERROR 5" MESSAGE. AS A RESULT OF THE ALLEGED ISSUE, THE PATIENT TOOK DECREASED DOSAGES OF MEDICATION. THE PATIENT TOOK 15 UNITS OF LEVEMIR INSULIN AND 15 UNITS OF HUMALOG INSULIN. THE PATIENT GUESSED ON HOW MUCH SLIDING-SCALE HUMALOG INSULIN TO TAKE. THE NEXT MORNING AT 3:00 AM, THE PATIENT HAD SYMPTOMS OF BLURRED VISION, AND FEELING SHAKY, SWEATY, AND LIGHTHEADED. THE PATIENT SUCCESSFULLY TREATED HIMSELF BY DRINKING ORANGE JUICE. THE PATIENT WAS NOT TESTED ON ANOTHER DEVICE DURING THE TIME OF CONCERN. THE REPORTED METER ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED. THIS COMPLAINT IS BEING REPORTED TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT HE DEVELOPED SYMPTOMS THAT CAN BE ASSOCIATED WITH SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN. IT IS NOT KNOWN WHAT THE DURATION OF THE 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 2765338

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Life Threatening| R