BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1869781 · Received October 14, 2010

    Report

    Report Number
    2939301-2010-09048
    Event Type
    Injury
    Date Received
    October 14, 2010
    Report Date
    October 1, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. 510K #K053529.

    Description of Event or Problem · 1

    THE MEDICAL SURVEILLANCE SPECIALIST (MSS) CLASSIFIED THIS COMPLAINT BASED ON CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) CUSTOMER SERVICE ON (B)(6) 2010 ALLEGING THAT THE ONETOUCH ULTRA2 METER IS GIVING INACCURATE RESULTS OF "113, 106, AND 148 MG/DL" COMPARED TO A 3 MONTH AVERAGE EQUIVALENT OF "344 MG/DL" OBTAINED THE HA1C. ON (B)(6) 2010, THIS MEDICAL SURVEILLANCE SPECIALIST CONTACTED THE PATIENT TO CLARIFY INFORMATION OBTAINED DURING THE INITIAL PHONE CALL. HOWEVER, THE PATIENT PROVIDED LIMITED INFORMATION. ACCORDING TO THE PATIENT, HIS READINGS OF "113, 106, AND 148 MG/DL" WERE OBTAINED 5 MONTHS PRIOR TO CONTACTING LFS. THE HA1C OF "344 MG/DL" EQUIVALENT WAS OBTAINED SOMETIME IN (B)(6) 2010. DURING THIS TIME, THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS OF "BLURRED VISION AND FLUSHING." THE PATIENT DID NOT RECALL WHAT BLOOD GLUCOSE HE OBTAINED ON THE SUBJECT METER PRIOR TO AND DURING THE ALLEGED SYMPTOMS. IT WOULD HAVE BEEN HELPFUL TO HAVE MORE DETAILS CONCERNING THE PATIENT'S DIABETES REGIMEN AND THE CIRCUMSTANCES SURROUNDING THE INCIDENT. DURING A DOCTOR'S OFFICE VISIT, THE PATIENT'S ORAL MEDICATION OF METFORMIN WAS INCREASED. SINCE HIS ORAL MEDICATION REGIMEN WAS INCREASED, HIS BLOOD GLUCOSE REPORTEDLY HAS NOT BEEN ELEVATED. ACCORDING TO THE TROUBLESHOOTING PERFORMED WITH CUSTOMER SERVICE, THE SUBJECT METER READINGS WERE PERFORMED 5 MONTHS PRIOR TO THE LAB RESULT. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED HE DEVELOPED SYMPTOMS THAT CAN BE ASSOCIATED WITH HYPERGLYCEMIA AFTER THE ALLEGED ISSUE BEGAN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Life Threatening