BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2841991 · Received November 21, 2012

    Report

    Report Number
    3008382007-2012-06579
    Event Type
    Injury
    Date Received
    November 21, 2012
    Report Date
    October 26, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Adverse Event
    Yes
    Product Problem
    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. THE 510K # IS K053529.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THAT HER ONETOUCH ULTRA2 METER READ INACCURATELY HIGH COMPARED TO ANOTHER DEVICE. THIS COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION, SINCE THE MEDICAL SURVEILLANCE SPECIALIST WAS UNABLE TO REACH THE PATIENT BY PHONE TO OBTAIN ADDITIONAL INFORMATION. THE PATIENT REPORTED THAT SHE OBTAINED BLOOD GLUCOSE READINGS OF "250 MG/DL" WITH THE SUBJECT METER AND "56 MG/DL" ON ANOTHER DEVICE, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE BETWEEN THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF LESS THAN OR EQUAL TO (B)(4). IT IS NOT KNOWN WHEN THE METER TO METER COMPARISON WAS PERFORMED. THE PATIENT INFORMED THE CCA THAT ON AN UNSPECIFIED DAY SHE BECAME "INCOHERENT" AND ALSO REPORTED SHE REQUIRED THE ASSISTANCE OF EMERGENCY SERVICES; HOWEVER, IT IS NOT KNOWN WHAT TREATMENT, IF ANY, THE PATIENT RECEIVED. THE CCA NOTED THAT THE PATIENT DECLINED TO ANSWER ANY QUESTIONS AND DISCONNECTED THE CALL. IT IS NOT KNOWN WHAT MEDICATIONS THE PATIENT TAKES TO MANAGE HER DIABETES, NOR IS IT KNOWN IF THE PATIENT MADE ANY ADJUSTMENTS TO HER USUAL DIABETES MANAGEMENT IN RESPONSE TO AN ALLEGED INACCURATE HIGH READING OBTAINED WITH THE SUBJECT METER. THIS REPORT IS MADE BASED ON THE INDICATION THAT THE PATIENT MAY HAVE RECEIVED MEDICAL INTERVENTION BY A HEALTHCARE PROFESSIONAL FOR SEVERE HYPOGLYCEMIA AND THE SUBJECT METER COULD NOT BE RULED OUT AS THE CAUSE OR CONTRIBUTOR TO THE EVENT.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R