BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3031884 · Received April 3, 2013

    Report

    Report Number
    3008382007-2013-06875
    Event Type
    Injury
    Date Received
    April 3, 2013
    Report Date
    March 17, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2013 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRA2 METER READ INACCURATELY HIGH COMPARED TO ANOTHER DEVICE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. IT IS NOT CLEAR WHEN THE ALLEGED ISSUE BEGAN. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "200, 190 AND 180 MG/DL" WITH THE SUBJECT METER AND "170, 160 AND 150 MG/DL" ON ANOTHER METER, PERFORMED WITHIN 30 MINUTES OF EACH OTHER, RESPECTIVELY. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS DO NOT EXCEED THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. THE PATIENT MANAGES HER DIABETES WITH ORAL MEDICATIONS (TYPE/ AMOUNT NOT SPECIFIED). IT IS NOT KNOWN IF THE PATIENT MADE CHANGES TO HER USUAL DOSE OF MEDICATIONS AT THE TIME OF THE ALLEGED ISSUE; HOWEVER, OVER THE LAST COUPLE MONTHS PRIOR TO CONTACTING LFS, THE PATIENT REPORTEDLY TOOK LESS FOOD/ DRINK. THE PATIENT CLAIMS SHE DEVELOPED SYMPTOMS OF BLURRED VISION. THE PATIENT ADMINISTERED SELF GLUCOSE TABLETS/ GLUCOSE GEL AS TREATMENT. NO ADDITIONAL TREATMENT WAS SPECIFIED. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT AND AN APPROVED SAMPLE SITE WAS USED FOR TESTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT REPORTEDLY DEVELOPED A SYMPTOM SUGGESTIVE OF A SERIOUS INJURY POSSIBLY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137023 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3374838

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Life Threatening| R