BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2863118 · Received December 10, 2012

    Report

    Report Number
    3008382007-2012-07490
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    November 28, 2012
    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
    LA, 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 HER ONETOUCH ULTRAMINI METER DISPLAYED AN "ERROR 5" MESSAGE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON (B)(6) 2012. THE PATIENT MANAGES HER DIABETES WITH GLIPIZIDE PILLS, HUMULIN 70/30 INSULIN AND LANTUS INSULIN. IT IS NOT KNOWN IF THE PATIENT MADE CHANGES TO HER USUAL DIABETES MANAGEMENT ROUTINE. A WEEK AFTER THE START OF THE ALLEGED ISSUE, THE PATIENT CLAIMS SHE HAD "HIGH BLOOD SUGAR" AND WAS TIRED. ON THE MORNING OF (B)(6) 2012, THE PATIENT REPORTEDLY VISITED HER PHYSICIAN'S OFFICE AND OBTAINED A BLOOD GLUCOSE RESULT OF "310 MG/DL" WITH THE PHYSICIAN'S METER. THE PATIENT WAS ADMINISTERED 15 UNITS HUMULIN 70/30 INSULIN AS TREATMENT. THE ALLEGED ISSUE WAS NOT RESOLVED WITH RETESTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE, DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AND RECEIVED TREATMENT FROM A HEALTH CARE PROFESSIONAL (HCP) 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 EUROPE, A DIVISION OF CILAG GMBH INTL 3168632

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Life Threatening| R