BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2110628 · Received June 1, 2011

    Report

    Report Number
    2939301-2011-04507
    Event Type
    Injury
    Date Received
    June 1, 2011
    Report Date
    May 16, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE TEST STRIPS INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: THE TEST STRIPS HAVE PASSED ALL TESTING WITH NO FAULTS FOUND. THE RETAIN TEST STRIPS ALSO PASSED ALL TESTING. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS/HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED TESTING WITH NO FAULTS FOUND. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED. 510(K) # IS K061118.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HIS ONETOUCH ULTRAMINI METER READ INACCURATELY HIGH COMPARED TO HIS EXPECTED RESULT. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN DURING THE EVENING THE FIRST WEEKEND OF (B)(6) 2011. THE PATIENT REPORTED A BLOOD GLUCOSE RESULT "75-100 POINTS HIGHER THAN EXPECTED." THE PATIENT DID NOT SPECIFY RESULTS OBTAINED. THE CCA WAS ADVISED THE PATIENT MANAGES HIS DIABETES WITH HUMALOG INSULIN AND LEVEMIR INSULIN. AT THE TIME OF THE ALLEGED ISSUE, THE PATIENT INCREASED HIS USUAL DOSE OF MEDICATION. ABOUT 4 HOURS AFTER THE ALLEGED ISSUE BEGUN, THE PATIENT CLAIMED HE FELT A SYMPTOM OF SHAKY. EMERGENCY MEDICAL SERVICES (EMS) WAS CONTACTED. THE PATIENT OBTAINED A BLOOD GLUCOSE RESULT OF "40 MG/DL" WITH THE EMS METER. THE PATIENT WAS GIVEN FOOD AND/ OR DRINK AS TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULT, AND REPORTEDLY DEVELOPED A SYMPTOM SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3062530

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Life Threatening| R