BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VITA METER

    MDR report key: 2152282 · Received July 7, 2011

    Report

    Report Number
    2939301-2011-05568
    Event Type
    Injury
    Date Received
    July 7, 2011
    Report Date
    June 27, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. 510K#:K082513.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT IN (B)(6) CONTACTED LIFESCAN TO REPORT THE ONE TOUCH VITA METER WAS GIVING INACCURATELY HIGH READINGS. ON (B)(6) 2011 THE TECHNICAL SERVICE REPRESENTATIVE (TSR) SPOKE WITH THE PATIENT TO OBTAIN AND VERIFY INFORMATION; HOWEVER THE PATIENT REFUSED TO SPEAK WITH THE TSR. THE SR. MEDICAL SURVEILLANCE SPECIALIST CLASSIFIED THE COMPLAINT BASED ON THE INFORMATION ORIGINALLY PROVIDED TO CUSTOMER SERVICE. FOR ONE YEAR, THE PATIENT ALLEGEDLY OBTAINED BLOOD GLUCOSE READINGS ON THE REPORTED METER THAT SHE CLAIMED WERE INACCURATELY HIGH COMPARED TO HER EXPECTED VALUES. THE PATIENT TOOK NO ACTIONS BASED ON THESE READINGS. APPROXIMATELY SIX MONTHS AGO, THE PATIENT EXPERIENCED THE SYMPTOM OF FATIGUE. THE PATIENT REPORTED THE FOLLOWING BLOOD GLUCOSE READINGS: ON (B)(6) 2011 192 MG/DL, ON (B)(6) 2011 189 MG/DL, ON (B)(6) 2011 205 MG/DL AND ON (B)(6) 2011 208 MG/DL. ON (B)(6) 2011, THE PATIENT VISITED HER PHYSICIAN, WHO TESTED HER BLOOD GLUCOSE LEVEL, BUT THE RESULT WAS NOT PROVIDED. THE PATIENT RECEIVED AN ADDITIONAL ORAL DIABETES MEDICATION JANUVIA, AND WAS HOSPITALIZED. THE PATIENT ALSO TAKES GLUCOPHAGE AND NITROGLYCERINE. IT WOULD HAVE BEEN HELPFUL TO DETERMINE THE PATIENT'S EXPECTED BLOOD GLUCOSE VALUES, HER METER READING AS TESTED BY THE PHYSICIAN, THE DATE OF HOSPITALIZATION, HER BLOOD GLUCOSE READINGS WHEN HOSPITALIZED, THE ADMITTING DIAGNOSIS AND TREATMENT RECEIVED. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. NO SPECIFIC DETAILS OF THE PATIENT'S HOSPITALIZATION WERE PROVIDED. THE PATIENT ALLEGEDLY WAS HOSPITALIZED AND RECEIVED ADDITIONAL DIABETES MEDICATIONS WHILE USING THE REPORTED METER AND OBTAINING ELEVATED METER READINGS. THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT VITA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3097110

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| L