BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2932641 · Received January 29, 2013

    Report

    Report Number
    3008382007-2013-01721
    Event Type
    Injury
    Date Received
    January 29, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 13, 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
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRA2 METER READ INACCURATELY COMPARED TO ANOTHER DEVICE. 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 ALLEGED ISSUE BEGAN ON (B)(6), 2013 AT 6PM. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF '139 MG/DL' WITH THE SUBJECT METER AND '36 MG/DL' 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 <= 30 MG/DL. THE PATIENT DOES NOT TAKE MEDICATIONS TO MANAGE HER DIABETES AND CONTINUED TO FOLLOW HER USUAL MANAGEMENT ROUTINE. PRIOR TO TESTING, THE PATIENT CLAIMS SHE FELT SYMPTOMS OF SHAKING AND SWEATING. THE PATIENT REPORTEDLY WENT TO THE EMERGENCY ROOM (ER) AND WAS ADMINISTERED INTRAVENOUS (IV) DEXTROSE (AND MAGNESIUM) AS TREATMENT. THE PATIENT WAS ALSO PUT ON A DIABETIC DIET. LATER THAT SAME EVENING, THE PATIENT OBTAINED BLOOD GLUCOSE RESULTS OF '139 MG/DL' WITH 2 OTHER METERS. 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 USES FOR TESTING. THE PATIENT DID NOT HAVE CONTROL SOLUTION TO PERFORM QUALITY CONTROL TESTING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY OBTAINED A BLOOD GLUCOSE RESULT SUGGESTIVE OF A SERIOUS INJURY FROM ANOTHER METER AND RECEIVED MEDICAL INTERVENTION FROM A HEALTH CARE PROFESSIONAL (HCP) AFTER THE REPORTED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38445 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3211438

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Life Threatening| R