BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1861401 · Received October 8, 2010

    Report

    Report Number
    2939301-2010-08921
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    September 25, 2010
    Report Date
    September 27, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. A 510K # IS K053529.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY-USER/REPORTER CONTACTED LIFESCAN (LFS) ON BEHALF OF THE LAY-USER/PATIENT ALLEGING THAT ONETOUCH ULTRA2 METER IS GIVING INACCURATE HIGH READING OF "86 MG/DL" COMPARED TO "53 MG/DL" ON THE HOSPITAL METER. ON (B)(6) 2010, THIS MEDICAL SURVEILLANCE SPECIALIST CONTACTED THE PATIENT TO CLARIFY INFORMATION OBTAINED DURING THE INITIAL PHONE CALL. THE PATIENT MANAGES HER DIABETES WITH SELF ADJUSTING INSULIN. THE PATIENT DOES NOT RECALL WHAT HAPPENED ON (B)(6) 2010 OR WHY SHE WENT TO THE EMERGENCY ROOM ON THE DAY OF CONCERN. REPORTEDLY, BETWEEN 5 AND 6 PM, THE PATIENT OBTAINED COMPARED HER BLOOD GLUCOSE READING OF "86 MG/DL" OBTAINED ON THE SUBJECT METER TO "53 MG/DL" ON THE HOSPITAL METER. AROUND THAT SOME TIME THE PATIENT RECEIVED IV GLUCOSE FROM THE HEALTHCARE PROVIDER. THE PATIENT ALLEGEDLY DID NOT HAVE ANY SYMPTOMS AT THE TIME OF CONCERN. IT IS NOT KNOWN WHAT READINGS SHE OBTAINED PRIOR TO THE ALLEGED MEDICAL TREATMENT ON THE DAY OF CONCERN AND HOW HER DIABETES WAS MANAGED PER THE LFS METER READINGS. ACCORDING TO THE TROUBLESHOOTING PERFORMED WITH CUSTOMER SERVICE, THE METER RESULTS WERE PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY RECEIVED MEDICAL TREATMENT SUGGESTIVE FOR HYPOGLYCEMIA AS A RESULT OF THE ALLEGED INACCURATE HIGH ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 3053689

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention