BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT SELECT METER

    MDR report key: 5224783 · Received November 16, 2015

    Report

    Report Number
    2939301-2015-49121
    Event Type
    Injury
    Date Received
    November 16, 2015
    Report Date
    October 31, 2015
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K072543
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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) 2015, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THAT HER ONETOUCH SELECT METER READ INACCURATELY HIGH IN COMPARISON TO RESULTS OBTAINED ON ANOTHER DEVICE. THE COMPLAINT WAS CLASSIFIED BASED ON CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT IN (B)(6) 2015 SHE OBTAINED RESULTS OF 144, 158, 125, 132, 224, 253, 278 AND 247MG/DL ON THE SUBJECT METER, WHICH SHE FELT WERE INACCURATELY HIGH IN COMPARISON TO RESULTS OF 112, 110 AND 102MG/DL ON A ONETOUCH ULTRA METER. THE TESTS WERE PERFORMED MORE THAN 30 MINUTES APART. THE PATIENT MANAGES HER DIABETES WITH ORAL MEDICATION, DIET AND EXERCISE AND CONTINUED TO TAKE HER USUAL DOSE OF METFORMIN PILLS IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT DENIED DEVELOPING ANY SYMPTOMS AS A RESULT OF THE ISSUE HOWEVER STATED THAT IN (B)(6) 2015 SHE WAS TREATED IN A DOCTOR'S OFFICE WITH GLUCOSE TABLETS OR GEL AND HAD HER BLOOD GLUCOSE TESTED ON A CLINIC METER, HOWEVER COULD NOT SPECIFY THE RESULTS OBTAINED. DURING TROUBLESHOOTING THE CCA NOTED THAT THE METER WAS SET TO THE CORRECT UNIT OF MEASURE AND AN APPROVED SAMPLE SITE WAS USED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED AS THE PATIENT RECEIVED MEDICAL INTERVENTION FOR A BLOOD GLUCOSE EXCURSION FROM A HEALTHCARE PROFESSIONAL AFTER THE ALLEGED METER ISSUE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755914 OT SELECT METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3541225

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R