BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 3233364 · Received July 18, 2013

    Report

    Report Number
    3008382007-2013-20273
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    July 7, 2013
    Report Date
    July 10, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K061118
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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 HIS ONETOUCH ULTRAMINI METER WAS PROMPTING AN ERROR 1 MESSAGE WHEN SHE WAS ATTEMPTING TO TEST HER BLOOD GLUCOSE. ACCORDING TO THE OT ULTRAMINI OWNER¿S MANUAL, AN ERROR 1 PROMPTS WHEN THERE IS A PROBLEM WITH THE METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE FIRST BEGAN ON (B)(6) 2013. THE PATIENT REPORTED USING NON ADJUSTING INSULIN TO MANAGE HIS DIABETES. THE PATIENT REPORTED MAKING NO CHANGES TO HIS USUAL DIET, ACTIVITY LEVEL OR MEDICATIONS ON THE DAY OF THE ALLEGED ISSUE. THE PATIENT REPORTED 10 MINUTES AFTER THE ALLEGED ISSUE OCCURRED HE DEVELOPED SYMPTOMS OF ¿SHAKES, DEHYDRATED AND FREQUENT URINATION.¿ THE PATIENT REPORTED ON (B)(6) 2013 AT 4 PM HE OBTAINED A READING OF ¿320 MG/DL¿ AND TREATED IT WITH INSULIN. THE PATIENT REPORTED ON (B)(6) 2013 AT 4 PM HE OBTAINED A READING OF ¿50 MG/DL¿ AND TREATED IT WITH ORANGE JUICE. THE PATIENT REPORTED HE ALSO RECEIVED TREATMENT ON (B)(6) 2013 HOWEVER DID NOT SPECIFY WHAT TYPE OF TREATMENT. AT THE TIME OF TROUBLESHOOTING THE CCA WAS NOT ABLE TO ASSIST THE PATIENT WITH TROUBLESHOOTING THE ALLEGED ISSUE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT BECAUSE THE REPORTER CLAIMS DUE TO THE ALLEGED ISSUE, THE PATIENT DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER THE ALLEGED ISSUE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336030 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3459319

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R