BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1081636 · Received July 22, 2008

    Report

    Report Number
    2939301-2008-01466
    Event Type
    Injury
    Date Received
    July 22, 2008
    Date of Event
    July 14, 2008
    Report Date
    July 14, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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

    ON JULY 14, 2008, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT A ONETOUCH ULTRA METER HAD A BATTERY INDICATOR ISSUE. THE MEDICAL AFFAIRS SPECIALIST (MAS) WAS ABLE TO CONTACT THE PATIENT TO OBTAIN ADDITIONAL INFORMATION. THE PATIENT TESTS HER BLOOD GLUCOSE TWO TIMES A DAY: ONCE IN THE MORNING BEFORE HAVING BREAKFAST AND AGAIN IN THE AFTERNOON. SHE ALSO TAKES LANTUS 6 UNITS AND REGULAR INSULIN ON A SLIDING SCALE TO MANAGE HER DIABETES. ON THE DAY BEFORE AT NIGHT, THE PATIENT CLAIMED THAT HER METER HAD A BATTERY INDICATOR ISSUE. THE NEXT MORNING, SHE TOOK HER USUAL DOSE OF 6 UNITS OF LANTUS AND REPORTEDLY BECAME "CLAMMY AND SWEATY" THREE HOURS LATER. THE PATIENT STATES THAT SHE BASED HER INSULIN INTAKE ON THE METER READINGS; THEREFORE, IF THE READINGS WERE LOW THAT MORNING, SHE MENTIONS THAT SHE WOULD NOT HAVE TAKEN THE 6 UNITS OF LANTUS. THE PATIENT REPORTEDLY ADMINISTERED SELF-TREATMENT WITH ORANGE JUICE AND PEANUT BUTTER WITH CRACKERS AND REPORTEDLY FELT BETTER. THE BATTERIES WERE THEN REPLACED AND A BLOOD GLUCOSE RESULT OF "293 MG/DL" WAS REPORTEDLY OBTAINED ON THE SUBJECT METER. THE MAS CONFIRMED WITH THE PATIENT THAT THE EMERGENCY MEDICAL SERVICES TEAM CAME AT A LATER TIME FOR ANOTHER INCIDENT UNRELATED TO THIS ONE. THIS WAS NOT A NEW OUT OF BOX PRODUCT. THE PATIENT DID NOT CHANGE THE BATTERY PER THE OWNER'S MANUAL. THERE WAS NO METER TRAUMA. THE PATIENT'S PRODUCTS ARE BEING REPLACED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSIONS: THE PATIENT CLAIMED THAT SHE DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2765925

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Life Threatening| R