BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2141797 · Received June 27, 2011

    Report

    Report Number
    2939301-2011-05271
    Event Type
    Injury
    Date Received
    June 27, 2011
    Date of Event
    June 10, 2011
    Report Date
    June 12, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. 510(K) # IS K053529.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRA2 METER WAS READING INACCURATELY HIGH COMPARED TO ANOTHER METER. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN ON (B)(6) 2011 AT 8:10AM. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "342, 352, AND 400 MG/DL" WITH THE SUBJECT METER AND "97 MG/DL" ON ANOTHER METER (BRAND UNKNOWN), PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. AS PART OF HIS DIABETES REGIMEN, THE PATIENT CLAIMED HE IS ON PRANDIN PILLS WITH DIET AND/OR EXERCISE. LATER THAT DAY, AT 2:30PM, THE PATIENT STATED HE ADMINISTERED 1 EXTRA DOSE OF PRANDIN AFTER THE ALLEGED ISSUE BEGAN. THE PATIENT REPORTED 1-1 ½ HOURS AFTER THE ALLEGED ISSUE BEGAN, HE WAS FEELING LIGHTHEADED AND SWEATY. AT 6:00PM LATER THAT EVENING, THE PATIENT INDICATED HE WENT TO URGENT CARE/CLINIC FOR ASSISTANCE. ACCORDING TO THE PATIENT, A BLOOD GLUCOSE TEST WAS PERFORMED BY THE DOCTOR/CLINIC METER WITH A RESULT OF "97 MG/DL". IT IS NOT KNOWN WHETHER THE PATIENT RECEIVED ADDITIONAL TREATMENT WHILE AT THE URGENT CARE/CLINIC SINCE THE CCA NOTED THE PATIENT WENT HOME AND FOLLOWED HIS NORMAL ROUTINE. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE PATIENT TESTED ON AN APPROVED SAMPLE SITE TO OBTAIN THE RESULTS FROM THE SUBJECT METER AND THE METER'S UNIT OF MEASURE WAS SET CORRECTLY. THE PATIENT DID NOT HAVE THE CONTROL SOLUTION AVAILABLE TO PERFORM A QUALITY CONTROL TEST. THE MSS WAS NOT ABLE TO CONFIRM WHETHER THE PATIENT'S SYMPTOMS WERE ASSOCIATED FOR A LOW OR HIGH BLOOD SUGAR SYMPTOMS. THEREFORE, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT 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 ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3037484

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening