BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2032068 · Received March 28, 2011

    Report

    Report Number
    2939301-2011-02656
    Event Type
    Injury
    Date Received
    March 28, 2011
    Date of Event
    March 12, 2011
    Report Date
    March 16, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 K053529.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT'S MOTHER CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PATIENT'S ONETOUCH ULTRA2 METER WAS READING INACCURATELY. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT'S MOTHER REPORTED THE ALLEGED ISSUE BEGAN ON (B)(6) 2011 AT 6:30AM. PER THE CCA DOCUMENTATION, THE PATIENT'S MOTHER WAS NOT ABLE TO SPECIFY THE BLOOD SUGAR READING(S) OBTAINED FROM THE SUBJECT METER. THE MOTHER INFORMED THE CCA THAT THE PATIENT MANAGES HER DIABETES WITH INSULIN. AFTER THE ALLEGED ISSUE BEGAN, THE MOTHER STATED THE PATIENT CONTINUED TO ADMINISTER HER USUAL DOSE OF 18 UNITS OF LANTUS INSULIN ON (B)(6) 2011 AT 12:15AM. BY 3:30AM THAT MORNING, THE MOTHER INDICATED THE PATIENT'S BLOOD SUGAR TESTED LOW THAT SHE WENT INTO A SEIZURE. ACCORDING TO THE MOTHER, EMERGENCY MEDICAL SERVICES (EMS) WAS NOTIFIED FOR ASSISTANCE. THE PATIENT'S MOTHER INDICATED THE PATIENT WAS TESTED BY THE EMS METER WITH A READING OF "61 MG/DL" AND WAS THEN ADMINISTERED IV GLUCOSE. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE MOTHER WAS NOT ABLE TO SPECIFY WHETHER THE SUBJECT METER'S UNIT OF MEASURE WAS SET CORRECTLY AT THE TIME OF TESTING AND THE MOTHER WAS NOT ABLE TO PERFORM A QUALITY CONTROL TEST SINCE SHE DID NOT HAVE THE CONTROL SOLUTION AVAILABLE . REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT'S MOTHER CLAIMS THAT THE PATIENT OBTAINED AN INACCURATE READING(S) ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULT(S), AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA REQUIRING HCP INTERVENTION AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3030905

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Life Threatening| R