BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 3081537 · Received April 29, 2013

    Report

    Report Number
    3008382007-2013-09258
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 2, 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
    NY, 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. TEST STRIP LOT NUMBER: NOT PROVIDED.

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE LAY USER/REPORTER, THE PATIENT'S HUSBAND, CONTACTED LIFESCAN TO REPORT THE ONE TOUCH ULTRAMINI METER WAS GIVING AN UNSPECIFIED ERROR MESSAGE. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION PROVIDED TO CUSTOMER SERVICE. ON (B)(6)2013 AT 5:00 PM THE PATIENT OBTAINED AN ERROR MESSAGE ON THE REPORTED METER; THE REPORTER WAS UNABLE TO SPECIFY WHICH ERROR MESSAGE OCCURRED. THE PATIENT WAS UNABLE TO OBTAIN A BLOOD GLUCOSE READING. THE PATIENT TOOK THE ACTION OF TAKING HER USUAL ORAL DIABETES MEDICATIONS, TYPE AND DOSE NOT SPECIFIED. TWELVE HOURS AFTERWARDS, THE PATIENT SUFFERED THE SYMPTOM OF PASSING OUT; SHE DID NOT SEEK ANY MEDICAL ATTENTION OR TREATMENT. THE ISSUE WAS NOT RESOLVED. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA AFTER SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE LEVEL DUE TO THE METER ISSUE. THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184509 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening