BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 4994419 · Received August 12, 2015

    Report

    Report Number
    2939301-2015-33606
    Event Type
    Injury
    Date Received
    August 12, 2015
    Report Date
    July 30, 2015
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K061118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    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 (B)(6) ALLEGING THAT THEIR ONETOUCH ULTRAMINI METER WAS READING INACCURATELY LOW COMPARED TO A LABORATORY DEVICE. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT ALLEGED THAT THE PRODUCT ISSUE BEGAN AT 6AM ON (B)(6) 2015. THE PATIENT REPORTED OBTAINING BLOOD GLUCOSE READINGS OF "233, 223 AND 174MG/DL" ON THE SUBJECT METER AND "340MG/DL" ON A LABORATORY DEVICE. THE TIME DIFFERENCE BETWEEN THESE READINGS EXCEEDED 30 MINUTES THEREFORE LIFESCAN CANNOT CONFIRM AN INACCURACY. THE PATIENT MANAGES THEIR DIABETES WITH PILLS, DIET AND EXERCISE. THE PATIENT REPORTED CONSUMING LESS FOOD/DRINK IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT DENIED DEVELOPING ANY SYMPTOMS HOWEVER REPORTED RECEIVING A DOSE OF RAPID INSULIN FROM AN HCP. AT THE TIME OF TROUBLESHOOTING THE CCA NOTED THAT THE UNIT OF MEASURE WAS SET CORRECTLY. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT RECEIVED TREATMENT FROM AN HCP WHILE USING THE SUBJECT METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531440 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3746345

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention