BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT SELECT METER

    MDR report key: 2482136 · Received March 7, 2012

    Report

    Report Number
    2939301-2012-02330
    Event Type
    Injury
    Date Received
    March 7, 2012
    Report Date
    February 24, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, 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. THE 510(K) # IS K072543.

    Description of Event or Problem · 1

    ON (B)(6) 2012 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH SELECT METER WAS NOT POWERING ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN ON (B)(6) 2012 (UNKNOWN TIME). AS PART OF HIS DIABETES REGIMEN, THE PATIENT CLAIMED HE IS ON INSULIN (TYPE NOT SPECIFIED). DUE TO THE ALLEGED ISSUE, THE PATIENT CLAIMED HE CONTINUED TO TAKE HIS USUAL DIABETES REGIMEN OF INSULIN (DOSE UNCLEAR) AS USUAL. THE PATIENT REPORTED 2 DAYS AFTER THE ALLEGED ISSUE BEGAN, HE BECAME SHAKY, WEAK, AND FELT FUNNY. THE PATIENT, HOWEVER, INDICATED HE DID NOT SEEK MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE PATIENT WAS NOT A 1ST TIME USER OF THE SUBJECT METER, THERE WAS NO MISUSED OF THE METER, THE CORRECT TEST STRIPS WERE USED, AND THE METER REQUIRED NO BATTERY REPLACEMENT. THE PATIENT, HOWEVER, WAS NOT ABLE TO TURN THE METER ON WITH THE POWER BUTTON AND TEST STRIP INSERTION. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT SELECT METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3076021

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Life Threatening