BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1081602 · Received July 25, 2008

    Report

    Report Number
    2939301-2008-01527
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    July 15, 2008
    Report Date
    July 19, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT LFS PRODUCT FOR EVALUATION, BUT HAS NOT YET RECEIVED THEM. IF THE LFS PRODUCT IS RETURNED, LIFESCAN WILL EVALUATE THEM AND, IF THE LFS PRODUCT DOES NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON JULY 19, 2008, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE ONETOUCH METER IS GIVING INACCURATE HIGH READINGS. THE PATIENT TESTS HIS BLOOD GLUCOSE MORE THAN 4 TIMES PER DAY AND TAKES INSULIN BASED ON A SLIDING SCALE PER THE LFS METER READINGS. ON THE EVE OF THE PATIENT'S ALLEGED MEDICAL INTERVENTION, THE PATIENT REPORTEDLY OBTAINED BLOOD GLUCOSE READINGS OF "395 MG/DL" AT 6:30 PM AND "267 MG/DL" AT 7:46 PM ON THE SUBJECT METER. BASED ON THE "267 MG/DL," THE PATIENT REPORTEDLY ADMINISTERED 16 UNITS OF NOVOLOG. ON THE MORNING OF THREE DAYS EARLIER, THE PATIENT'S WIFE CLAIMED SHE FOUND THE PATIENT UNCONSCIOUS AND UNRESPONSIVE. THE PATIENT'S WIFE REPORTEDLY PANICKED AND CONTACTED HER DAUGHTER FOR ASSISTANCE. HER DAUGHTER THEN CALLED 911. WHEN THE PARAMEDICS ARRIVED AT THE PATIENT'S HOUSE, THE PATIENT WAS TESTED AT "23 OR 25 MG/DL" ON THE EMT METER. THE PATIENT WAS TREATED IV (UNSPECIFIED TYPE) AND WAS ALSO GIVEN INJECTION (UNSPECIFIED TYPE). THE PATIENT WAS TAKEN TO THE HOSPITAL WHERE HE STAYED OVERNIGHT. DURING HIS STAY AT THE HOSPITAL, THE PATIENT COMPARED HIS METER READING TO THE HOSPITAL METER READING. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "286 MG/DL" WITH A LIFESCAN METER AND "120 MG/DL" ON ANOTHER METER, PERFORMED WITHIN UNSPECIFIED MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <=30% AND/OR <=30 MG/DL. THE PATIENT WAS ADVISED BY HIS DOCTOR TO REPLACE THE SUBJECT METER. IT WOULD HAVE BEEN HELPFUL TO KNOW IF THE PATIENT'S TESTING FREQUENCY, DIABETES MEDICATION, AND THE EVENTS PRIOR TO THE PATIENT PASSING OUT SUCH AS PHYSICAL ACTIVITY, FOOD INTAKE, INSULIN DOSE, AND READINGS OBTAINED ON THE SUBJECT METER. IN ADDITION, IT WOULD HAVE BEEN HELPFUL TO KNOW WHAT TIME THE PATIENT PASSED OUT, DID THE PATIENT'S WIFE ATTEMPT TO TEST THE PATIENT WHILE HE WAS UNRESPONSIVE, THE PARAMEDIC'S TREATMENT, AND THE PATIENT'S READING, DIAGNOSE, AND TREATMENT AT THE HOSPITAL. DURING TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE VERIFIED THAT THE TESTING TECHNIQUE WAS CORRECT, THE PUNCTURE AREA WAS CLEANED APPROPRIATELY, AND THE REPORTED METER READINGS WERE CONFIRMED IN THE METER'S MEMORY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT HAD SYMPTOMS THAT WERE SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER HE TOOK INSULIN PER THE ALLEGED INACCURATE LFS METER READING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2712317

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| L| R