BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2160589 · Received July 13, 2011

    Report

    Report Number
    2939301-2011-05778
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 7, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    SERIAL # OF METER IS (B)(4). 510 (K) K053529. 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

    THE LAY USER / PATIENT CONTACTED LFS (B)(6) ON (B)(6) 2011 ALLEGING INACCURATE HIGH READINGS ON HER ONE TOUCH ULTRA 2 METER. A MEDICAL SURVEILLANCE SPECIALIST (MSS) SENT FOLLOW UP QUESTIONS AND OBTAINED THE FOLLOWING INFORMATION. THE PATIENT MENTIONED THAT THE PATIENT HAD OBTAINED A 384 MG/DL ON THE LFS METER ON (B)(6) 2011 AND DID NOT EXHIBIT ANY SYMPTOMS. DUE TO THE ALLEGED HIGH READING THE PATIENT TOOK 10 UNITS NOVORAPID INSULIN. THE PATIENT DID NOT EAT AFTER OBTAINING THE 384 MG/DL READING AND APPROXIMATELY AN HOUR LATER THE PATIENT LOST CONSCIOUSNESS AND WOKE UP 20 MINUTES LATER. THE PATIENT TESTED THEIR BLOOD GLUCOSE AND OBTAINED A 40 MG/DL AND THEN SELF-TREATED WITH FOOD/DRINK. THE PATIENT CONTACTED THEIR PHYSICIAN; HOWEVER, DID NOT RECEIVE ANY MEDICAL TREATMENT AND WAS NOT TESTED ON ANOTHER DEVICE. A NORMAL READING FOR THE PATIENT IS BETWEEN 100-200 MG/DL. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE ALLEGED HIGH READING, SHE TOOK INSULIN AND AN HOUR LATER LOST CONSCIOUSNESS AND HAD TO SELF-TREAT 20 MINUTES LATER WITH FOOD/DRINK FOR A BLOOD GLUCOSE READING OF 40 MG/DL.

    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 Life Threatening| R