BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PROFILE METER

    MDR report key: 1051873 · Received May 21, 2008

    Report

    Report Number
    2939301-2008-00852
    Event Type
    Injury
    Date Received
    May 21, 2008
    Report Date
    April 29, 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 EVAL, BUT HAS NOT YET REC'D 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

    THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) IN 2008 AND ALLEGED THAT HER ONE TOUCH PROFILE METER WAS READING INACCURATELY HIGH. THE MEDICAL AFFAIRS SPECIALIST WAS UNABLE TO REACH THE PT AFTER SEVERAL ATTEMPTS VIA PHONE. A LETTER WAS SENT TO THE ADDRESS PROVIDED. THE PT REPORTED THAT THE ALLEGED ISSUE FIRST OCCURRED ON THE SAME DAY AT 8:00 AM (MORNING OF THE CALL TO LFS). SHE REPORTED OBTAINING A RESULT OF 222 MG/DL ON THE SUBJECT METER, HOWEVER, A RESULT OF 202 MG/DL WAS VERIFIED IN THE METER'S MEMORY. THE PT ALSO MENTIONED THAT SHE EXPERIENCED HER HANDS SHAKING AFTER THE REPORTED ISSUE BEGAN. HOWEVER, SHE REPORTEDLY TOOK NO DIABETES TREATMENT ACTIONS FOLLOWING THE ISSUE AND DID NOT RECEIVE/REQUIRE ANY MEDICAL TREATMENT OR INTERVENTION. THE PT WAS NOT TESTED ON ANY OTHER DEVICE. AT THE TIME OF TROUBLESHOOTING, IT WAS VERIFIED THAT THE METER WAS SET IN THE RIGHT UNIT OF MEASUREMENT (MG/DL). THE PT'S TESTING TECHNIQUE WAS REVIEWED TO BE CORRECT AND SHE WAS ALSO CLEANING THE PUNCTURE AREA PROPERLY. SHE WAS WALKED THROUGH A CONTROL SOLUTION TEST, WHICH PASSED WITHIN RANGE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT CLAIMED SHE HAD A SYMPTOM OF UNEXPLAINED SHAKINESS AFTER OBTAINING A REPORTEDLY HIGH RESULT. UNEXPLAINED SHAKINESS CAN BE ASSOCIATED WITH SEVERE HYPOGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH PROFILE METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2700322

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Life Threatening