BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT SELECT METER

    MDR report key: 2038086 · Received April 4, 2011

    Report

    Report Number
    2939301-2011-02758
    Event Type
    Injury
    Date Received
    April 4, 2011
    Date of Event
    March 31, 2011
    Report Date
    April 4, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. 510(K) # IS K072543.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A REPORTER FOR THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THE PATIENT'S ONETOUCH SELECT METER DISPLAYED A BATTERY INDICATOR. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN 3 MONTHS AGO PRIOR TO CONTACTING LFS. THE CCA WAS ADVISED THE PATIENT MANAGES HIS DIABETES WITH ORAL MEDICATION (TYPE/ AMOUNT NOT SPECIFIED). IT IS NOT KNOWN WHAT ACTION THE PATIENT TOOK AT THE TIME OF THE ALLEGED ISSUE. ON (B)(6) 2011, THE REPORTER CLAIMED THE PATIENT FELT HIGH BLOOD GLUCOSE SYMPTOMS OF DIZZY, LIGHT HEADED AND "COLLAPSED." THE PATIENT OBTAINED A BLOOD GLUCOSE RESULT OF "32 MMOL/L" WITH ANOTHER DEVICE. THE PATIENT WAS TAKEN TO THE HOSPITAL WHERE HE WAS ADMINISTERED INTRAVENOUS (IV) FLUIDS AND INSULIN (TYPE/ AMOUNT NOT SPECIFIED) AS TREATMENT. THE REPORTER STATED THE PATIENT WAS KEPT AT THE HOSPITAL OVERNIGHT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THERE WAS NO MISUSE OF THE SUBJECT METER AND THE BATTERIES HAVE BEEN RECENTLY REPLACED SEVERAL TIMES. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY RECEIVED MEDICAL INTERVENTION FROM A HEALTH CARE PROFESSIONAL (HCP) AFTER THE REPORTED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT SELECT METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 2984622

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| L| R