BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT SELECT METER

    MDR report key: 2747664 · Received September 17, 2012

    Report

    Report Number
    2939301-2012-10712
    Event Type
    Injury
    Date Received
    September 17, 2012
    Date of Event
    August 25, 2012
    Report Date
    August 31, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    PMA / PMN Number
    K072543
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE PATIENT CALLED THE MSS BACK ON (B)(6) /2012 AT 10:02AM PST WITH ADDITIONAL INFORMATION REGARDING THE INJURY. THIS COMPLAINT REMAINS AS AN ADVERSE EVENT. THE PATIENT CONFIRMED ON (B)(6) 2012 IN THE MORNING, SHE OBTAINED A READING OF "500MG/DL" ON HER LFS METER. THE PATIENT REPORTED SHE DID NOT ADMINISTER ANY TREATMENT IN RESPONSE TO THAT READING. THE PATIENT HAD SYMPTOMS OF "SUGAR CRAZY AND FELT WEAK" WHICH SHE ASSOCIATED WITH HIGH BLOOD GLUCOSE. THE PATIENT'S NEPHEW REPORTEDLY CALLED EMERGENCY MEDICAL SERVICES (EMS) SOMETIME AFTER THE ALLEGED ISSUE FIRST OCCURRED. THE PATIENT REPORTED EMS ARRIVED A SHORT TIME LATER AND OBTAINED A READING OF "300MG/DL" ON THEIR METER. THE PATIENT REPORTED EMS DID NOT ADMINISTER ANY TREATMENT IN RESPONSE TO THE "300MG/DL" READING AND ADVISED HER NOT TO USE HER LFS METER ANYMORE. THE PATIENT REPORTED EMS STAYED WITH HER "FOR A LITTLE WHILE" AND HER BLOOD GLUCOSE "WENT DOWN A LITTLE." HOWEVER THE PATIENT WAS UNABLE TO RECALL THE EXACT READINGS. THE PATIENT REFUSED TRANSPORT TO THE HOSPITAL. THE PATIENT REPORTED SHE TAKES GLIPIZIDE 10MG AND GLUCOTROL XL 10MG TWICE A DAY AND NON ADJUSTING INSULIN (UNKNOWN TYPE AND DOSE) IN THE EVENING. THE PATIENT REPORTED SHE NORMALLY TESTS 3 TIMES A DAY AND HER TYPICAL RESULTS ARE ABOUT "119MG/DL."

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH SELECT METER WAS READING INACCURATELY HIGH WHEN SHE RAN A CONTROL SOLUTION TEST AND WAS READING INACCURATELY HIGH COMPARED TO AN EMERGENCY MEDICAL SERVICES (EMS) METER. THE MEDICAL SURVEILLANCE SPECIALIST WAS UNABLE TO REACH THE PATIENT FOR ADDITIONAL INFORMATION. THIS COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. ON (B)(6) 2012, IN THE EVENING, THE PATIENT REPORTED THE ALLEGED ISSUE FIRST OCCURRED. IN ADDITION THE PATIENT REPORTED OBTAINING AN INACCURATE HIGH READING OF "500MG/DL" ON HER LFS METER, COMPARED WITH "300MG/DL" OBTAINED ON AN EMS METER. IT IS UNKNOWN HOW MUCH TIME PASSED IN BETWEEN THE TWO RESULTS. THE PATIENT REPORTED TAKING SELF ADJUSTING INSULIN (TYPE AND DOSE UNKNOWN) AS WELL AS NON INSULIN INJECTABLES (TYPE AND DOSE UNKNOWN) TO MANAGE HER DIABETES. IT IS UNKNOWN IF THE PATIENT MADE ANY CHANGES TO HER USUAL DIET, ACTIVITY LEVEL OR MEDICATIONS ON THE DAY OF THE ALLEGED ISSUE. HOWEVER, THE PATIENT REPORTED HAVING SYMPTOMS OF "SUGAR CRAZY AND FELT WEAK" RIGHT AFTER THE ALLEGED ISSUE STARTED. THE PATIENT REPORTED ON (B)(6) 2012, SHE WAS HOSPITALIZED AND WAS TREATED BY A HEALTHCARE PROFESSIONAL (HCP). IT IS UNKNOWN IF ANY ADDITIONAL READINGS WERE OBTAINED WHILE THE PATIENT WAS IN THE HOSPITAL OR WHAT TYPE OF TREATMENT WAS GIVEN TO THE PATIENT. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE TEST STRIP VIAL WAS NOT CRACKED OR BROKEN. THE PATIENT'S TEST STRIPS WERE IN GOOD CONDITION AND WERE NOT COUNTERFEIT. HOWEVER, A CONTROL SOLUTION TEST WAS NOT COMPLETED DUE TO THE PATIENT NOT HAVING CONTROL SOLUTION AVAILABLE. THE PATIENT WAS UNABLE TO RECALL THE CONTROL SOLUTION TEST RESULT THAT WAS READING HIGH. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT BECAUSE THE PATIENT ALLEGED SHE WAS TREATED BY AN HCP AFTER THE ALLEGED ISSUE OCCURRED. HOWEVER, THE COMPARISON OF METER VS. EMS METER IS NOT VALID SINCE THE TIME ELAPSED BETWEEN READINGS WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT SELECT METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3283533

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| L| R