BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2851787 · Received November 30, 2012

    Report

    Report Number
    3008382007-2012-06962
    Event Type
    Injury
    Date Received
    November 30, 2012
    Date of Event
    November 21, 2012
    Report Date
    November 23, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HIS ONETOUCH ULTRA2 METER READ INACCURATELY. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON (B)(6) 2012 AROUND LUNCHTIME. THE PATIENT REPORTED OBTAINING A BLOOD GLUCOSE RESULT OF "173 MG/DL" WITH THE SUBJECT METER. THE PATIENT MANAGES HIS DIABETES WITH NOVOLOG INSULIN. DUE TO THE ALLEGED RESULT, THE PATIENT ADMINISTERED SELF AN INCREASED DOSE OF INSULIN (11 UNITS). SEVERAL HOURS AFTER, THE PATIENT CLAIMS HE FELT SYMPTOMS OF NAUSEA AND SWEAT. THE PATIENT REPORTEDLY OBTAINED A BLOOD GLUCOSE RESULT OF "49 MG/DL" WITH THE SUBJECT METER. THE PATIENT DID NOT SPECIFY ANY TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT AND AN APPROVED SAMPLE SITE WAS USED FOR TESTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE OBTAINED AN INACCURATE READING ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULT, AND 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 ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3374838

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening