BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1001988 · Received February 21, 2008

    Report

    Report Number
    2939301-2008-00208
    Event Type
    Injury
    Date Received
    February 21, 2008
    Date of Event
    February 4, 2008
    Report Date
    February 11, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVALUATION, BUT HAS NOT YET RECEIVED THEM. IF EITHER THE METER OR STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE IT/THEM AND, IF EITHER THE METER OR STRIPS 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 IN GERMANY, THE PATIENT'S DAUGHTER, CONTACTED LIFESCAN (LFS) ALLEGING THE ONE TOUCH ULTRA 2 METER WAS GIVING INACCURATELY HIGH READINGS. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) CONTACTED THE REPORTER ON BEHALF OF THE MEDICAL AFFAIRS SPECIALIST TO OBTAIN AND CONFIRM INFORMATION. ON A WEEK EARLIER AT AN UNSPECIFIED TIME BETWEEN 2:00 AM AND 3:00 AM, THE PATIENT ALLEGEDLY EXPERIENCED THE SYMPTOMS OF 'FEELING SICK,' TINGLING IN HER FINGERS AND A NUMB TONGUE. THE PATIENT WAS UNABLE TO STATE WHETHER OR NOT SHE TESTED HER BLOOD GLUCOSE LEVEL WHILE SYMPTOMATIC. THE PATIENT ADMINISTERED SELF-TREATMENT WITH ORAL GLUCOSE, AND FELT BETTER AFTERWARDS. SHE DID NOT SEEK MEDICAL ATTENTION. AT AN UNSPECIFIED TIME ON THE EVENING PRIOR TO THE EVENT, ON EIGHT DAYS PRIOR TO ORIGINAL DATE, THE PATIENT OBTAINED THE BLOOD GLUCOSE READING OF 'APPROXIMATELY 400 MG/DL' ON THE REPORTED METER. BASED ON THIS METER READING, THE PATIENT TOOK AN INSULIN DOSE OF 34 UNITS TO 36 UNITS HUMALOG INSULIN. THE REPORTER COULD NOT CONFIRM WHAT MEALS THE PATIENT HAD TAKEN THAT DAY. THE PATIENT TESTS HER BLOOD GLUCOSE LEVEL TWICE PER DAY; AND HER READINGS VARY GREATLY. THE PATIENT TAKES HUMALOG INSULIN ON A SLIDING SCALE TWICE PER DAY, AND ADJUSTS HER DOSES BASED ON THE METER READINGS. THE REPORTER ALSO STATED THAT DURING A RECENT HOSPITAL STAY, THE PATIENT OBTAINED A BLOOD GLUCOSE READING ON HER ONE TOUCH ULTRA 2 METER THAT WAS 'ABOUT 50 MG/DL' HIGHER THAN A HOSPITAL METER READING. NO SPECIFIC DATA WAS AVAILABLE. THE PATIENT TAKES MEDICATIONS FOR HIGH BLOOD PRESSURE, AND ANTI-COAGULANTS. THE PATIENT WAS UNABLE TO PROVIDE HER HEMATOCRIT VALUE, BUT CLAIMED SHE IS NOT ANEMIC. DURING THE TROUBLESHOOTING TELEPHONE CALL, THE TSR DETERMINED THE METER WAS SET TO THE CORRECT UNIT OF MEASURE, AND THE PATIENT'S TESTING TECHNIQUE WAS CORRECT. THE METER AND TEST STRIPS WERE REPLACED. IT WOULD HAVE BEEN HELPFUL DETERMINE THE PATIENT'S EXACT METER READINGS, THE TIMES OF HER MEALS AND INSULIN DOSES, AND THE PATIENT'S HEMATOCRIT. THE PATIENT ALLEGEDLY BECAME HYPOGLYCEMIC AFTER TAKING AN INSULIN DOSE BASED ON AN ELEVATED METER READING, AND REQUIRED SELF-TREATMENT WITH GLUCOSE TO RESOLVE THE SYMPTOMS. THEREFORE THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2755739

    Patients

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