BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2080003 · Received May 6, 2011

    Report

    Report Number
    2939301-2011-03729
    Event Type
    Injury
    Date Received
    May 6, 2011
    Report Date
    April 19, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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) 2011 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA METER WAS READING INACCURATELY. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN ON APRIL 19 (YEAR NOT SPECIFIED) AT 7:30 AM. THE PATIENT REPORTED SHE OBTAINED ALLEGED READINGS OF "386 AND 38 MG/DL" WITH THE SUBJECT METER, PERFORMED GREATER THAN 20 MINUTES OF EACH OTHER. AS PART OF HER DIABETES MANAGEMENT ROUTINE, THE PATIENT INDICATED SHE IS ON INSULIN. DUE TO THE READING OF "386 MG/DL", THE PATIENT CLAIMED SHE ADMINISTERED 50 UNITS OF INSULIN (TYPE NOT SPECIFIED). A COUPLE OF HOURS AFTER THE ALLEGED ISSUE BEGAN, THE PATIENT REPORTED FEELING SWEATY AND WEAK. IT IS NOT KNOWN WHAT KIND OF TREATMENT, IF ANY, THE PATIENT RECEIVED AFTER THE ALLEGED ISSUE BEGAN. AT THE TIME OF THE ALLEGED ISSUE, THE PATIENT DENIED TESTING ON ANY OTHER BLOOD GLUCOSE DEVICE. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER'S UNIT OF MEASURE WAS SET CORRECTLY; HOWEVER, 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 CLAIMS SHE OBTAINED INACCURATE READINGS ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULT OF "386 MG/DL", 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 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3025479

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Life Threatening