BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2143369 · Received June 29, 2011

    Report

    Report Number
    2939301-2011-05342
    Event Type
    Injury
    Date Received
    June 29, 2011
    Date of Event
    May 27, 2011
    Report Date
    June 14, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ((B)(6) 2011)- THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 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 K062195.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA METER WAS READING INACCURATELY HIGH. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE LAY USER/PATIENT ON (B)(6) 2011 AND OBTAINED THE FOLLOWING INFORMATION: THE PATIENT TESTS FOUR TIMES A DAY AND MANAGES HER DIABETES WITH 7 UNITS OF HUMALOG INSULIN (WITH DINNER) AND 35 UNITS OF LANTUS AT BEDTIME. THE PATIENT INDICATED HER BLOOD GLUCOSE RANGE (BEFORE BEDTIME) IS BETWEEN "130-146MG/DL". THE PATIENT CORRECTED AND CLARIFIED THAT THE ALLEGED ISSUE BEGAN ON (B)(6) 2011 (BETWEEN 9:30-10PM). THE PATIENT CONFIRMED SHE OBTAINED A BLOOD GLUCOSE RESULT OF "150MG/DL" WITH THE SUBJECT METER. IN RESPONSE TO THE REPORTED METER ISSUE, THE PATIENT CORRECTED AND CLARIFIED SHE ADMINISTERED HER USUAL DOSE OF LANTUS INSULIN AND SEVERAL MINUTES LATER WENT TO BED. APPROXIMATELY TWO HOURS AFTER THE ALLEGED ISSUE BEGAN, THE PATIENT CONFIRMED AND CLARIFIED SHE WOKE UP FEELING WEAK, CONFUSED, AND PERSPIRING PROFUSELY. IMMEDIATELY AFTER THE ONSET OF HER SYMPTOMS, THE PATIENT INDICATED SHE ADMINISTERED TREATMENT BY CONSUMING CEREAL, PEANUT BUTTER, AND ORANGE JUICE. AFTER OBTAINING A BLOOD GLUCOSE RESULT OF "50MG/DL" WITH THE SUBJECT METER (20-30 MINUTES LATER) THE PATIENT STATED SHE CONSUMED MORE FOOD AND BEGAN TO FEEL BETTER WITHIN 45 MINUTES. THE PATIENT DENIED TESTING HER BLOOD GLUCOSE WITH ANOTHER DEVICE. AT THE TIME OF TROUBLESHOOTING, THE CSR VERIFIED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT (MG/DL). REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER, ADMINISTERED HER USUAL DOSE OF INSULIN BASED ON HER READING, AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA 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. 3108520

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Life Threatening| R