BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1923456 · Received December 13, 2010

    Report

    Report Number
    2939301-2010-10685
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    November 30, 2010
    Report Date
    November 30, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE HAS PASSED ALL TESTING WITH NO FAULTS FOUND. THE RETAIN TEST STRIPS ALSO PASSED ALL TESTING. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A SECOND FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    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 K062195.

    Description of Event or Problem · 1

    ON (B)(6) 2010, A REPORTER FOR THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THE PATIENT'S ONETOUCH ULTRA METER READ INACCURATELY HIGH COMPARED TO HIS EXPECTED RESULT. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE CCA WAS ADVISED THE PATIENT MANAGES HIS DIABETES WITH LANTUS INSULIN (50 UNITS) AND LISPRO INSULIN (3 UNITS ONLY IF BLOOD GLUCOSE IS OVER 100 MG/DL). THE REPORTER DID NOT SPECIFY WHEN THE ALLEGED PRODUCT ISSUE BEGAN. ON (B)(6) 2010 AT 645AM, THE REPORTER STATED THE PATIENT WOKE UP WITH SYMPTOMS OF SWEATING AND "FEELING SICK." AT 745AM, THE REPORTER STATED THE PATIENT OBTAINED A BLOOD GLUCOSE RESULT OF "106 MG/DL" WITH THE SUBJECT METER. THE REPORTER ADMINISTERED THE PATIENT LANTUS AND LISPRO INSULIN ALONG WITH A BIGGER BREAKFAST THAN USUAL. SOMETIME AFTER THAT, THE REPORTER CLAIMED THE PATIENT WENT INTO A "DIABETIC COMA." THE PATIENT'S SPEECH WAS SLURRED AND "FELL OFF TO THE SIDE OF HIS WHEEL CHAIR." THE PARAMEDICS WERE CONTACTED AND ARRIVED AT THE PATIENT'S HOME BY 830AM. THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM (ER). THE REPORTER WAS ADVISED THE PATIENT HAD LOW BLOOD PRESSURE AND OBTAINED A BLOOD GLUCOSE RESULT OF ABOUT "70 MG/DL" WITH AN ER/ HOSPITAL DEVICE. BY 9AM THAT SAME MORNING, THE PATIENT WAS GIVEN MORE FOOD AND/ OR DRINK AS TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT. THE PATIENT DID NOT HAVE CONTROL SOLUTION TO TEST THE SUBJECT METER. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTER CLAIMED THE PATIENT OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER, WAS ADMINISTERED INSULIN BASED ON THE ALLEGED RESULT, 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 ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3062355

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening| R