BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1001987 · Received February 21, 2008

    Report

    Report Number
    2939301-2008-00209
    Event Type
    Injury
    Date Received
    February 21, 2008
    Date of Event
    February 12, 2008
    Report Date
    February 12, 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/PATIENT IN GERMANY CONTACTED LIFESCAN (LFS) ALLEGING THE ONE TOUCH ULTRA2 METER WAS GIVING INACCURATELY HIGH READINGS. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) CONTACTED THE PATIENT TO OBTAIN AND VERIFY INFORMATION; HOWEVER, THE PATIENT REFUSED TO SPEAK WITH THE TSR. THE SR. MEDICAL AFFAIRS SPECIALIST CLASSIFIED THE COMPLAINT BASED ON THE INFORMATION ORIGINALLY PROVIDED. ON AN UNSPECIFIED DATE, BETWEEN 10:50 PM AND 11:50 PM, THE PATIENT OBTAINED THE BLOOD GLUCOSE READING OF 148 MG/DL ON THE REPORTED METER, WHICH WAS HIGH COMPARED TO HIS EXPECTED VALUES. AT THAT TIME, THE PATIENT WAS EXPERIENCING NO SYMPTOMS OF HIGH OR LOW BLOOD GLUCOSE LEVELS. BASED ON THIS METER READING, THE PATIENT TOOK AN INCREASED DOSE OF ACTRAPHANE 30/70 INSULIN, TAKING 29 UNITS INSTEAD OF HIS USUAL 25 UNITS. AT 3:00 AM EARLY THE NEXT MORNING, THE PATIENT AWOKE EXPERIENCING THE SYMPTOMS OF IMPAIRED VISION AND JITTERING. THE PATIENT TESTED HIS BLOOD GLUCOSE LEVEL WHILE SYMPTOMATIC, AND OBTAINED A READING OF 46 MG/DL. FOLLOWING THIS READING, THE PATIENT ADMINISTERED SELF-CARE BY CONSUMING 'GRAPE SUGAR', AND FELT BETTER AFTERWARDS. HE DID NOT SEEK ANY MEDICAL ATTENTION. THE PATIENT TAKES ACTRAPHANE 30/70 INSULIN 12 UNITS IN THE MORNING AND 25 UNITS IN THE EVENING; HE ALSO ADJUSTS THE DOSES BASED ON METER READINGS AND CARBOHYDRATE INTAKE. THE PATIENT TAKES ADDITIONAL UNITS OF INSULIN WHEN HIS EVENING BLOOD GLUCOSE READING IS GREATER THAN 100 MG/DL. HE TAKES NO OTHER DIABETES MEDICATIONS. THE PATIENT TESTS HIS BLOOD GLUCOSE LEVEL FOUR TIMES PER DAY. DURING THE TROUBLESHOOTING TELEPHONE CALL, THE TSR DETERMINED THE METER WAS PROGRAMMED FOR THE CORRECT UNIT OF MEASURE, AND THE PATIENT'S TESTING TECHNIQUE WAS CORRECT. QUALITY CONTROL TESTING WAS PERFORMED DURING THE CALL, WITH PASSING RESULTS. IT WOULD HAVE BEEN HELPFUL TO DETERMINE THE PATIENT'S EXPECTED METER READINGS, HIS SPECIFIC SLIDING SCALE REGIMEN, HIS BLOOD GLUCOSE READINGS ON THE DAY PRIOR TO THE EVENT, AND WHAT MEALS AND MEDICATIONS HAD BEEN TAKEN THAT DAY. THE PATIENT ALLEGEDLY BECAME HYPOGLYCEMIC AFTER HE TOOK ADDITIONAL INSULIN BASED ON A METER READING. IT IS NOT CLEAR THE PATIENT'S RESULTS WERE INACCURATE. THE RESULT OBTAINED WHILE THE PATIENT WAS SYMPTOMATIC CORRELATED WITH HIS SYMPTOMS AND TREATMENT,. THE PASSING QUALITY CONTROL TEST RESULT INDICATES THE METER AND TEST STRIPS WERE FUNCTIONING APPROPRIATELY. HOWEVER, AS THE PATIENT ALLEGEDLY SUFFERED HYPOGLYCEMIC SYMPTOMS FOLLOWING AN INSULIN DOSE BASED ON AN ELEVATED METER READING AND TREATED HIMSELF WITH ORAL SUGAR, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2736467

    Patients

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