BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 3380760 · Received October 2, 2013

    Report

    Report Number
    2939301-2013-04503
    Event Type
    Injury
    Date Received
    October 2, 2013
    Report Date
    September 24, 2013
    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
    CT, US
    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) ALLEGING HER ONE TOUCH ULTRAMINI METER READ INACCURATELY ERRATIC WHEN PERFORMING CONSECUTIVE BLOOD GLUCOSE TESTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED INACCURACY BEGAN IN ¿(B)(6) 2013¿. AT AN UNSPECIFIED DATE/TIME, THE PATIENT REPORTED OBTAINING BLOOD GLUCOSE RESULTS OF ¿120, 103, 127, 106 MG/DL¿ WITH THE SUBJECT METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY THE CALCULATED DIFFERENCE BETWEEN THESE GLUCOSE RESULTS MEETS THE EXPECTED VALUE OF (B)(4). IT IS NOT KNOWN WHAT MEDICATIONS, IF ANY, THE PATIENT TAKES TO MANAGE HER DIABETES. THE PATIENT STATED THAT SHE CONTINUED WITH HER USUAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE ALLEGED INACCURATE RESULT(S). THE PATIENT CLAIMED, AT AN UNSPECIFIED TIME AFTER THE ALLEGED ISSUE OCCURRED, SHE DEVELOPED SYMPTOMS OF ¿BLURRED VISION¿. THE PATIENT DENIED RECEIVING ANY MEDICAL TREATMENT. DURING TROUBLESHOOTING, THE CCA CONFIRMED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE SETTING. THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION AT THE TIME TO TEST THE SUBJECT METER AND TEST STRIPS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SIGNS/SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497784 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening