BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1133251 · Received August 21, 2008

    Report

    Report Number
    2939301-2008-01915
    Event Type
    Injury
    Date Received
    August 21, 2008
    Date of Event
    August 15, 2008
    Report Date
    August 16, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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

    IN 2008, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA2 METER WAS READING INACCURATE HIGH. THE MEDICAL AFFAIRS SPECIALIST (MAS) SPOKE WITH THE PATIENT ON AUGUST 19, 2008 AND OBTAINED THE FOLLOWING INFORMATION. THE PATIENT REPORTED THAT SHE STARTED OBTAINING HIGHER THAN USUAL READINGS (GREATER THAN "200 MG/DL") APPROXIMATELY 1 WEEK PRIOR TO CONTACTING LFS. ON TWO DAYS BEFORE THE ORIGINAL DATE, THE PATIENT STATED SHE CONTACTED HER DOCTOR BECAUSE SHE WAS CONCERNED ABOUT THE CONSISTENT HIGHER READINGS SHE WAS OBTAINING ON THE SUBJECT METER. THE PATIENT CLAIMED HER DOCTOR ADVISED HER TO INCREASE HER BEDTIME INSULIN (LANTUS) FROM 20 UNITS TO 40 UNITS AS A RESULT OF THE HIGHER READINGS. ON THE DAY PRIOR TO ORIGINAL DATE, THE PATIENT REPORTED OBTAINING A PRE-BREAKFAST READING OF "151 MG/DL," ADMINISTERED 4 UNITS OF NOVOLOG (BASED ON SLIDING SCALE) AND THEN ATE. THE PATIENT STATED SHE WAS FEELING "FINE" AT THE TIME OF THAT READING. WITHIN 2 HOURS OF OBTAINING THAT RESULT, THE PATIENT INDICATED SHE STARTED TO SWEAT PROFUSELY AND BECAME "IRRITABLE." THE PATIENT CLAIMED SHE TESTED ON THE SUBJECT METER AT THE TIME OF THE SYMPTOMS AND OBTAINED A READING OF "261 MG/DL." DESPITE HER FEELINGS THAT HER BLOOD GLUCOSE WAS RUNNING LOW, THE PATIENT ADMINISTERED 8 UNITS OF NOVOLOG INSULIN (SLIDING SCALE) BUT ALSO ATE. THE PATIENT MENTIONED THAT SHE FELT BETTER SOMETIME AFTERWARDS. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE PATIENT WAS USING THE INCORRECT TESTING TECHNIQUE TO APPLY THE SAMPLE. THE PATIENT INFORMED THE MAS THAT SHE DID RUN A CONTROL SOLUTION TEST ON THE SUBJECT METER AND THE RESULT FELL WITHIN THE TEST STRIP RANGE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED READING AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2830219

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening| R