BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2790063 · Received October 15, 2012

    Report

    Report Number
    2939301-2012-12049
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    September 17, 2012
    Report Date
    September 27, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    PMA / PMN Number
    K061118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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) 2012, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING AN ISSUE WITH MISSING SEGMENTS ON HIS ONETOUCH ULTRAMINI METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN IN (B)(6) 2012. THE PATIENT MANAGES HIS DIABETES WITH ORAL MEDICATIONS AND INSULIN (TYPES/ AMOUNTS NOT SPECIFIED). THE PATIENT REPORTEDLY CONTINUED TO TAKE HIS USUAL DOSE OF MEDICATIONS FOR THE LAST 2 WEEKS PRIOR TO CONTACTING LFS. ON (B)(6) 2012, THE PATIENT CLAIMS HE FELT A SYMPTOM OF THIRSTY. THE PATIENT DENIED RECEIVING MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THERE WAS NO INDICATION OF MISUSE. 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
    1 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Life Threatening