BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1827387 · Received September 7, 2010

    Report

    Report Number
    2939301-2010-07654
    Event Type
    Injury
    Date Received
    September 7, 2010
    Date of Event
    August 27, 2010
    Report Date
    August 27, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. 510 (K) # IS K053529.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING A BATTERY INDICATOR ISSUE WITH A ONE TOUCH ULTRA 2 METER. THE PATIENT INDICATED THAT THE ALLEGED ISSUE STARTED ON (B)(6) 2010, AT 3:48 PM. THE PATIENT CLAIMED THAT SHE DEVELOPED SYMPTOMS OF SHAKINESS AND TIREDNESS 30 MINUTES AFTER THE ALLEGED ISSUE BEGAN SINCE SHE DID NOT KNOW WHAT HER BLOOD GLUCOSE LEVEL WAS. THE PATIENT DENIED THAT SHE RECEIVED ANY TREATMENT BECAUSE OF THE ALLEGED ISSUE. THE ALLEGED ISSUE WAS NOT 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 SHE DEVELOPED SYMPTOMS THAT CAN BE ASSOCIATED WITH SEVERE HYPOGLYCEMIA 30 MINUTES AFTER THE ALLEGED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 2905423

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Life Threatening