BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2873367 · Received December 14, 2012

    Report

    Report Number
    3008382007-2012-08203
    Event Type
    Injury
    Date Received
    December 14, 2012
    Report Date
    November 20, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K062195
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) TO REPORT THAT HIS ONETOUCH ULTRA METER WAS DISPLAYING THREE DASHES "---". PER THE OWNER'S BOOKLET, THE DASHES APPEAR WHEN THE SUBJECT METER HAS NOT BEEN CODED. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED ISSUE BEGAN ON THE MORNING OF (B)(6) 2012. IT IS NOT KNOWN WHAT MEDICATIONS, IF ANY, THE PATIENT TAKES TO MANAGE HIS DIABETES. THE PATIENT DENIED TAKING ANY ACTION REGARDING HIS USUAL DIABETES MANAGEMENT REGIMEN AS A RESULT OF THE ALLEGED METER ISSUE. THE PATIENT REPORTED THAT THE DAY AFTER THE ISSUE STARTED HE DEVELOPED SYMPTOMS OF "DRY MOUTH AND FREQUENT URINATION". THE PATIENT DENIED RECEIVING MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE ALLEGED METER ISSUE WAS RESOLVED WITH TRAINING. THE CCA ASSISTED THE PATIENT WITH CODING THE SUBJECT METER. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT DEVELOPED SIGNS/SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA AFTER THE ALLEGED METER ISSUE STARTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3336736

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening