BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 779899 · Received November 8, 2006

    Report

    Report Number
    2939301-2006-01536
    Event Type
    Injury
    Date Received
    November 8, 2006
    Date of Event
    October 25, 2006
    Report Date
    October 25, 2006
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    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

    ON OCTOBER 25, 2006 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THE ONE TOUCH ULTRA 2 METER WAS GIVING INACCURATELY HIGH READINGS. ON NOVEMBER 1, 2006 THE MEDICAL AFFAIRS SPECIALIST (MAS) SPOKE WITH THE PATIENT TO OBTAIN AND VERIFY INFORMATION. THE MAS ALSO REVIEWED THE RECORDED TELEPHONE CALL. ON OCTOBER 25, 2006 AT 6:12 AM THE PATIENT OBTAINED THE FASTING BLOOD GLUCOSE READINGS OF 217 MG/DL, 106 MG/DL AND 232 MG/DL ON THE REPORTED METER WITHIN 10 MINUTES OF EACH OTHER. AT THAT TIME, THE PATIENT WAS EXPERIENCING THE SYMPTOM OF SHAKING, NEARLY PASSING OUT, AND SHE FELL. FOLLOWING THE USE OF THE METER, THE PATIENT ADMINISTERED SELF-CARE BY CONSUMING A TWO-LITER BOTTLE OF SODA AND CEREAL. THE PATIENT'S HUSBAND CONTACTED EMERGENCY SERVICES. PARAMEDICS ARRIVED AT 6:50 AM AND OBTAINED A BLOOD GLUCOSE READING ON THEIR METER OF 141 MG/DL. THE PARAMEDICS DID NOT PROVIDE ANY FURTHER TREATMENT. THE PATIENT REFUSED TO BE TRANSPORTED TO THE EMERGENCY ROOM. AFTER THE PATIENT HAD OBTAINED THE FASTING METER READINGS, SHE HAD PERFORMED A CONTROL SOLUTION TEST, WITH PASSING RESULTS. THE EVENING BEFORE THE EVENT, ON OCTOBER 24, 2006 AT 9:43 PM, THE PATIENT HAD OBTAINED THE BLOOD GLUCOSE READING OF 102 MG/DL, WHICH WAS AN EXPECTED RESULT. THE PATIENT TAKES NOVOLOG INSULIN 8 UNITS IN THE MORNING, 6 UNITS AT LUNCH, AND 8 UNITS IN THE EVENING. THE PATIENT ALSO TAKES 26 UNITS NPH INSULIN AT NIGHT. THE PATIENT HAS OBTAINED HIGHER THAN EXPECTED METER READINGS FOR ONE MONTH. HER PHYSICIAN INCREASED HER DOSE OF NPH INSULIN FROM 10 UNITS TO 16 UNITS TO NOW 26 UNITS BASED ON THE METER READINGS. THE PATIENT'S EXPECTED FASTING BLOOD GLUCOSE VALUES ARE 80 MG/DL TO 120 MG/DL. THE PATIENT IS PREGNANT, AND HAS BEEN DIABETIC SINCE THE AGE OF TWELVE. THE PATIENT TESTS HER BLOOD GLUCOSE LEVEL FOUR TIMES PER DAY. SHE DOES NOT HAVE A BACKUP METER. THE CUSTOMER CARE ADVOCATE (CCA) DETERMINED DURING THE TROUBLESHOOTING TELEPHONE CALL THE PATIENT'S TESTING TECHNIQUE WAS CORRECT, THE TEST STRIPS WERE WITHIN EXPIRATION DATING AND IN GOOD CONDITION, AND THE METER WAS PROGRAMMED FOR THE CORRECT UNIT OF MEASURE AND CALIBRATION CODE NUMBER. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. WHILE EXPERIENCING SYMPTOMS THAT SUGGESTED HYPOGLYCEMIA, THE PATIENT OBTAINED ELEVATED METER READINGS. THE PATIENT ADMINISTERED SELF-TREATMENT WITH FOOD AND DRINK TO ALLEVIATE 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 2634933

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Life Threatening| R