BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA EASY METER

    MDR report key: 2874463 · Received December 14, 2012

    Report

    Report Number
    3008382007-2012-07838
    Event Type
    Injury
    Date Received
    December 14, 2012
    Date of Event
    December 8, 2012
    Report Date
    December 10, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    METER WAS REPLACED. THE 510 (K) IS K061118.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED LFS (B)(4) ON (B)(6) 2012 ALLEGING THAT HIS ONE TOUCH ULTRA EASY METER DOES NOT POWER ON. THE PATIENT MENTIONED THAT THE ALLEGED ISSUE BEGAN ON (B)(6) 2012 . DUE TO THE ALLEGED ISSUE THE PATIENT WAS UNABLE TO TEST HIS BLOOD GLUCOSE. DURING THE LATE MORNING OF (B)(6) 2012, THE PATIENT HAD DEVELOPED SYMPTOMS OF FEELING DIZZY, SHAKY AND SWEATY. THE PATIENT'S WIFE NOTICED HIS SYMPTOMS AND TREATED HIM WITH A SNACK. THE PATIENT FELT BETTER AFTER TREATMENT. THE PATIENT DENIED GOING TO THE HOSPITAL OR SEEKING ANY OTHER FURTHER MEDICAL ATTENTION DUE TO THE ALLEGED ISSUE. THE PATIENT WAS NOT TESTED ON ANOTHER DEVICE. WHILE TROUBLESHOOTING IT WAS NOTED THAT THERE WAS MISUSE OF THE PRODUCT AND THE ALLEGED ISSUE WAS RESOLVED. THE PATIENT'S METER WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE METER NOT POWERING ON, THE PATIENT WAS UNABLE TO TEST, DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AND HIS WIFE TREATED HIM WITH A SNACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA EASY METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3239167

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Life Threatening| R