BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1955390 · Received January 10, 2011

    Report

    Report Number
    2939301-2011-00311
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    October 22, 2010
    Report Date
    December 22, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. 510(K) # IS K062195.

    Description of Event or Problem · 1

    ON (B)(6), 2010 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA METER WAS READING INACCURATELY HIGH COMPARED TO FEELING/NORMAL RESULT(S). THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE TO THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS ON (B)(6), 2011 TO OBTAINED/VERIFIED THE FOLLOWING INFORMATION. THE PATIENT INFORMED THE MSS THAT HER TESTING FREQUENCY IS TWICE DAILY AND MANAGES HER DIABETES WITH ORAL MEDICATIONS OF METFORMIN (850MG 3X DAILY) AND ACTOS (45MG 1X DAILY). THE PATIENT REPORTED OBTAINING AN ALLEGED HIGH READING OF "143 MG/DL" WITH THE SUBJECT METER THAT BEGAN ON (B)(6), 2010 AT 8:00PM; WHICH SHE CONSIDERED WAS NOT WITHIN HER NORMAL BLOOD READINGS OF NO MORE THAN "120 MG/DL". PRIOR TO OBTAINING THE ALLEGED HIGH READING, THE PATIENT INDICATED SHE ADMINISTERED HER USUAL ORAL DOSE OF DIABETES MEDICATIONS AT 5:30PM THAT DAY. THE PATIENT CLAIMED SHE WAS FEELING NERVOUS, SWEATY, AND LIGHTHEADED 2 ½ HOURS AFTER THE ALLEGED ISSUE BEGAN; HOWEVER SHE COULD NOT CONFIRM WHETHER THE SYMPTOMS WERE ASSOCIATED AS HIGH OR LOW BLOOD SUGAR SYMPTOMS. THE PATIENT CONFIRMED SHE DID NOT RECEIVE ANY MEDICAL TREATMENT DUE TO THE ALLEGED SYMPTOMS, BUT MENTIONED THAT HER SYMPTOMS CLEARED UP ABOUT AN HOUR LATER. AT THE TIME OF TROUBLESHOOTING, THE CCA VERIFIED THAT THE PATIENT TESTED ON AN APPROVED SAMPLE SITE AND THE UNIT OF MEASURE ON THE SUBJECT METER WAS SET CORRECTLY. THE PATIENT DID NOT HAVE THE CONTROL SOLUTION AVAILABLE TO PERFORM A QUALITY CONTROL TEST. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3052607

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Life Threatening