BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT SELECT METER

    MDR report key: 2234172 · Received September 6, 2011

    Report

    Report Number
    2939301-2011-08525
    Event Type
    Injury
    Date Received
    September 6, 2011
    Date of Event
    July 19, 2011
    Report Date
    August 19, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) K072543. 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 PHARMACIST CONTACTED LIFESCAN (LFS) (B)(4) ON (B)(6) 2011 ALLEGING INACCURATE HIGH READINGS ON THE PATIENT'S ONE TOUCH SELECT METER. A MEDICAL SURVEILLANCE SPECIALIST (MSS) SENT FOLLOW UP QUESTIONS AND THE CUSTOMER CARE ADVOCATE (CCA) WAS UNSUCCESSFUL IN GETTING A HOLD OF THE PATIENT. THE PHARMACIST MENTIONED THAT THE PATIENT FIRST NOTICED THE ALLEGED HIGH READINGS ON (B)(6) 2011. THE PATIENT ALLEGEDLY OBTAINED A 225 MG/DL ON THEIR LFS METER AND LESS THAN 30 MINUTES LATER, THE PATIENT TESTED ON ANOTHER DEVICE AND OBTAINED A 195 MG/DL AND ANOTHER READING, WHICH THE PATIENT COULD NOT RECALL. THE PHARMACIST WAS UNABLE/UNWILLING TO VERIFY WHETHER THE PATIENT EXHIBITED ANY SYMPTOMS. ON (B)(6) 2011, THE PATIENT WENT TO THE PHYSICIAN'S OFFICE AND WAS TREATED WITH GLUCOSE TABLETS/ GLUCOSE GEL AND WAS NOT TESTED ON ANOTHER DEVICE. AT THIS TIME, THERE IS NO INFORMATION ON WHY THE PATIENT WENT TO THE PHYSICIAN'S OFFICE AND THE READING THE PATIENT HAD OBTAINED ON THEIR LFS METER PRIOR TO VISITING THE PHYSICIAN. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE REPORTER ALLEGED THAT DUE TO THE ALLEGED INACCURATE READING, THE PATIENT VISITED THE PHYSICIAN AND WAS TREATED WITH GLUCOSE GEL/ GLUCOSE TABLETS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT SELECT METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3077558

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Life Threatening| R