BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT SELECT METER

    MDR report key: 2033591 · Received March 30, 2011

    Report

    Report Number
    2939301-2011-02685
    Event Type
    Injury
    Date Received
    March 30, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 7, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) # IS 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 LAY USER / PATIENT CONTACTED LFS ON (B)(6) 2011 ALLEGING INACCURATE HIGH READINGS ON THEIR ONE TOUCH SELECT METER. A MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNSUCCESSFUL IN GETTING A HOLD OF THE PATIENT AND SENT A LETTER TO THE PATIENT TO OBTAIN FURTHER CLINICAL INFORMATION. THE PATIENT MENTIONED THAT ON THE NIGHT OF (B)(6) 2011 THE PATIENT TESTED THEIR BLOOD GLUCOSE AND OBTAINED A 520 MG/DL, 542 MG/DL AND A 575 MG/DL. READINGS WERE NOT DONE BACK TO BACK. THE PATIENT IS ON INSULIN. APPROXIMATELY 5 HOURS LATER, THE PATIENT DEVELOPED SYMPTOMS OF FEELING SHAKY AND NAUSEATED. THE PATIENT DID NOT SELF-TREAT OR SEEK ANY MEDICAL ATTENTION DUE TO THE ALLEGED ISSUE. THE PRODUCT WAS REPLACED. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. IT WOULD HAVE BEEN HELPFUL TO KNOW THE PATIENT'S DIABETES REGIMEN, WHETHER THE PATIENT TOOK INSULIN BASED ON THE ALLEGED HIGH READINGS ON (B)(6) 2011 AND HOW MUCH THEY HAD TAKEN. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE ALLEGED HIGH READING, THEY LATER DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT SELECT METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3065214

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Life Threatening