BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2934043 · Received January 30, 2013

    Report

    Report Number
    3008382007-2013-01849
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 29, 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
    UK
    Reporter Occupation
    PATIENT

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING HER ONETOUCH ULTRA2 METER READ INACCURATELY HIGH COMPARED TO ANOTHER DEVICE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON (B)(6) 2013. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "8.7 MMOL/L" WITH THE SUBJECT METER AND "6 MMOL/L" ON ANOTHER METER, 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 <= 1.7 MMOL/L. THE PATIENT MANAGES HER DIABETES WITH INSULIN (TYPE/ AMOUNT NOT SPECIFIED). IT IS NOT KNOWN IF THE PATIENT MADE CHANGES TO HER USUAL DIABETES MANAGEMENT ROUTINE. AFTER THE START OF THE ALLEGED ISSUE, THE PATIENT CLAIMS SHE FELT LOW BLOOD GLUCOSE SYMPTOMS OF SWEATING, CONFUSION AND LIPS WERE TREMBLING. THE PATIENT REPORTEDLY WAS AT THE HOSPITAL AT THE TIME OF THE ALLEGED ISSUE. A HEALTH CARE PROFESSIONAL (HCP) GAVE THE PATIENT A GLUCOSE DRINK AS TREATMENT. 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. THE CCA WAS NOT ABLE TO WALK THE PATIENT THROUGH QUALITY CONTROL TESTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. 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
    40728 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Life Threatening| R