BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONT TOUCH ULTRASMART METER

    MDR report key: 1689120 · Received May 10, 2010

    Report

    Report Number
    2939301-2010-03622
    Event Type
    Injury
    Date Received
    May 10, 2010
    Report Date
    April 21, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    LAY USER/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 APRIL 21, 2010, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT A ONE TOUCH ULTRASMART METER READ INACCURATELY ERRATIC. THE PATIENT INDICATED THAT THE ALLEGED ISSUE STARTED AROUND (B) (6), 2010, AT AN UNSPECIFIED TIME. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "445 AND 290 MG/DL" WITH A LIFESCAN METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <=20% AND/OR <=20 MG/DL. AT AN UNCLEAR TIME AFTER THE ALLEGED ISSUE BEGAN, THE PATIENT CLAIMED THAT HE DEVELOPED LOW SYMPTOMS OF SHAKINESS, SWEATING, JITTERINESS, CONFUSION, AND WEAKNESS. THE PATIENT CLAIMED THAT THE SYMPTOMS DEVELOPED BECAUSE OF THE REPORTED ISSUE. THE PATIENT DENIED THAT HE RECEIVED ANY TREATMENT AS A RESULT OF THE ALLEGED ISSUE. IT WOULD HAVE BEEN HELPFUL TO KNOW THE FOLLOWING INFORMATION: THE PT'S TESTING FREQUENCY, HIS MEDICATION AND DIABETES MANAGEMENT REGIMENS, WHAT DATE/TIME THE SYMPTOMS DEVELOPED, WHAT ACTIONS THE PT TOOK BEFORE THE SYMPTOMS DEVELOPED, WHAT METER READINGS HE OBTAINED BEFORE AND AFTER THE SYMPTOMS STARTED, WHAT DATE/TIME THE LAST METER READING WAS OBTAINED BEFORE THE SYMPTOMS BEGAN, AND WHAT ACTIONS THE PATIENT TOOK BASED ON THE LAST METER HE OBTAINED BEFORE THE SYMPTOMS DEVELOPED. THE PT REPORTEDLY PERFORMED A CONTROL SOLUTION TEST THAT PASSED. 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 PT CLAIMED THAT HE DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONT TOUCH ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2946371

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Life Threatening