BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1860748 · Received October 7, 2010

    Report

    Report Number
    2939301-2010-08911
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    September 21, 2010
    Report Date
    September 21, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT. THE 510K #K053529.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THE ONETOUCH ULTRA2 METER WAS GIVING INACCURATE LOW READING OF "150 AND 111 MG/DL" COMPARED TO HER AVERAGE READING OF "200 MG/DL". THIS MEDICAL SURVEILLANCE SPECIALIST CONTACTED THE PATIENT ON (B)(6) 2010 TO CLARIFY INFORMATION OBTAINED DURING THE INITIAL PHONE. THE PATIENT MANAGES HER DIABETES WITH SELF ADJUSTING INSULIN AND TESTS HER BLOOD GLUCOSE 5 TIMES PER DAY. ON (B)(6) 2010, THE PATIENT CLAIMED THAT SHE DEVELOPED HIGH SYMPTOMS OF "ANXIETY, NAUSEOUS, AND JITTERY" WHILE OBTAINING HIGH READINGS ON THE SUBJECT METER. HER BLOOD GLUCOSE USUALLY RUNS AROUND 200 MG/DL AS SHE REGULATES HER DIABETES WITH 100 UNITS OF LANTUS AND TAKES AN AVERAGE OF 90 UNITS OF HUMALOG PER DAY. THE ALLEGED INACCURATE LOW READINGS OF "150 MG/DL AND 111 MG/DL" BEGAN ON (B)(6) 2010. AS A RESULT OF THE LFS METER READINGS, THE PATIENT CLAIMED THAT SHE MANAGED HER DIABETES BY TAKING MORE FOOD ON THE EVENING OF (B)(6) 2010. IN THE MORNING, SHE ALLEGEDLY OBTAINED "LOW READINGS" ON THE SUBJECT METER WHILE HER SYMPTOMS OF "ANXIETY, NAUSEOUS, JITTERY" PROGRESSIVELY INCREASED. SHE FELT THAT HER BLOOD GLUCOSE SHOULD HAVE BEEN AROUND 300 MG/DL BASED ON THE WAY SHE WAS FEELING AT THE TIME. ON (B)(6) 2010, SHE REPORTEDLY INCREASED HER INSULIN AND ADMINISTERED 10 UNITS OF HUMALOG 3 TIMES OVER THE COURSE OF THE DAY. SHE EVENTUALLY WENT TO THE EMERGENCY ROOM. THE PATIENT'S BLOOD GLUCOSE WAS TESTED AT "220 MG/DL" ON THE HOSPITAL METER. SHE WAS TREATED WITH ADDITIONAL INSULIN BY THE HEALTHCARE PROVIDER AND WAS SENT HOME SOON AFTER. ACCORDING TO THE TROUBLESHOOTING PERFORMED WITH CUSTOMER SERVICE, THE PATIENT DID NOT HAVE CONTROL SOLUTION TO PERFORM A QUALITY TEST. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED SHE RECEIVED INSULIN TREATMENT SUGGESTIVE FOR HYPERGLYCEMIA AFTER SHE MANAGED HER DIABETES BASED ON ALLEGEDLY LOW READINGS OBTAINED ON THE LFS METER FOR 3 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 3046347

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R