BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1780009 · Received August 2, 2010

    Report

    Report Number
    2939301-2010-06125
    Event Type
    Injury
    Date Received
    August 2, 2010
    Date of Event
    July 2, 2010
    Report Date
    July 12, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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) 2010, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING AN "ERROR 2" AND "ERROR 5" ISSUE WITH A ONE TOUCH ULTRA METER. THE REPORTER INDICATED THAT THE ERROR MESSAGE ISSUES STARTED ON (B)(6) 2010, AT 7:00 AM. A HALF HOUR AFTER THE ALLEGED ISSUE BEGAN, THE PATIENT CLAIMED THAT HE DEVELOPED SYMPTOMS OF WEAKNESS, SWEATING, DIZZINESS, AND BLURRED VISION. THE PATIENT DENIED THAT HE RECEIVED ANY TREATMENT BECAUSE OF THE ALLEGED ISSUES. THE ALLEGED "ERROR 3" AND "ERROR 5" ISSUES WERE RESOLVED WITH TROUBLESHOOTING. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT HE DEVELOPED SYMPTOMS WHICH CAN BE ASSOCIATED WITH SEVERE HYPOGLYCEMIA AFTER THE ALLEGED ISSUES BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 3019665

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening