BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 3070001 · Received April 22, 2013

    Report

    Report Number
    3008382007-2013-08534
    Event Type
    Injury
    Date Received
    April 22, 2013
    Report Date
    March 28, 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
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(4) 2013 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING SHE WAS UNABLE TO TEST BECAUSE HER ONETOUCH ULTRAMINI METER WAS IN THE SETTINGS MODE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE FIRST OCCURRED THE WEEK PRIOR TO CONTACTING LFS. THE PATIENT DID NOT REPORT WHAT MEDICATIONS SHE TAKES TO MANAGE HER DIABETES OR IF SHE MADE ANY CHANGES TO HER USUAL DIABETES MANAGEMENT ROUTINE. THE PATIENT REPORTED A FEW HOURS LATER, SHE DEVELOPED SYMPTOMS OF "SHAKINESS". THE PATIENT DENIED RECEIVING ANY TREATMENT IN RESPONSE TO THE REPORTED SYMPTOMS. AT THE TIME OF TROUBLESHOOTING, THE CCA WAS ABLE TO ASSIST THE PATIENT TO RESOLVE THE ALLEGED ISSUE WITH TRAINING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE WAS UNABLE TO TEST DUE TO THE ALLEGED ISSUE AND DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173096 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3387954

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening