BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1843141 · Received September 23, 2010

    Report

    Report Number
    2939301-2010-08345
    Event Type
    Injury
    Date Received
    September 23, 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
    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.THE 510 (K) # IS K053529.

    Description of Event or Problem · 1

    ON AUGUST 27, 2010, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT A ONE TOUCH ULTRA 2 METER READ INACCURATELY ERRATIC. THE PATIENT INDICATED THAT THE ALLEGED ISSUE STARTED ON (B)(6) 2010, AT 10:00 AM. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "318, 320, AND 336 MG/DL" WITH A LIFESCAN METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS DOES NOT EXCEED THE EXPECTED VALUE OF <= 20% AND/OR <= 20 MG/DL. THE PATIENT CLAIMED, HOWEVER, THAT SHE DEVELOPED SYMPTOMS OF SHAKINESS AND DIZZINESS DUE TO THE ALLEGED ISSUE ON (B)(6) 2010. THE PATIENT DENIED THAT SHE RECEIVED ANY TREATMENT BECAUSE OF THE ALLEGED ISSUE. AS A RESULT OF THE ALLEGED ISSUE, THE PATIENT TOOK A USUAL DOSE OF ORAL MEDICATION FOR DIABETES. IT WOULD HAVE BEEN HELPFUL TO KNOW THE FOLLOWING INFORMATION: THE PATIENT¿S TESTING FREQUENCY, HER MEDICATION AND DIABETES MANAGEMENT REGIMENS, WHAT DATE/TIMES THE REPORTED RESULTS WERE OBTAINED, WHAT HER LAST METER READING WAS BEFORE THE SYMPTOMS DEVELOPED, WHAT DATE/TIME THE LAST READING WAS OBTAINED, WHAT TIME THE SYMPTOMS DEVELOPED, AND WHAT ACTIONS THE PATIENT TOOK BEFORE AND AFTER THE SYMPTOMS DEVELOPED. IN ADDITION, IT WOULD HAVE BEEN HELPFUL TO KNOW IF THE PATIENT TESTED HER BLOOD GLUCOSE WHILE FEELING SYMPTOMATIC. 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 A SYMPTOM OF SHAKINESS WHICH CAN BE ASSOCIATED WITH SEVERE HYPOGLYCEMIA TWO DAYS 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. 3009675

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Life Threatening