BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1243788 · Received November 24, 2008

    Report

    Report Number
    2939301-2008-03210
    Event Type
    Injury
    Date Received
    November 24, 2008
    Report Date
    November 11, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    IN 2008, THE LAY-USER/PATIENT CONTACTED LIFESCAN ALLEGING THAT A ONE TOUCH ULTRA METER HAD A CALCODING ISSUE. THE PATIENT CLAIMED THAT SHE WAS UNABLE TO CODE THE REPORTED METER. SHE INDICATED THAT THE ALLEGED METER ISSUE STARTED ON THE SAME DAY, AT 9:30 AM. AS A RESULT OF THE ALLEGED ISSUE, THE PATIENT REPORTEDLY ADMINISTERED SELF-CARE BY CONSUMING MORE FOOD/DRINK. AROUND 1:00 PM THAT SAME DAY, THE PATIENT CLAIMED THAT SHE DEVELOPED UNSPECIFIED SYMPTOMS OF FEELING LOW. THE PATIENT DENIED RECEIVING MEDICAL TREATMENT. IT WOULD HAVE BEEN HELPFUL TO KNOW THE FOLLOWING INFORMATION: THE PATIENT'S TESTING FREQUENCY, HER MEDICATION AND DIABETES MANAGEMENT REGIMENS, WHAT SPECIFIC SYMPTOMS THE PATIENT HAD, AND WHAT ACTIONS THE PATIENT TOOK BEFORE AND AFTER THE SYMPTOMS DEVELOPED. IN ADDITION, IT WOULD HAVE BEEN HELPFUL TO KNOW IF THE PATIENT ATE BREAKFAST OR LUNCH ON THE DAY OF THE EVENT, WHAT HER LAST BLOOD GLUCOSE READING WAS BEFORE THE ALLEGED METER ISSUE BEGAN, AND WHEN THE LAST RESULT WAS OBTAINED. THE ALLEGED METER ISSUE WAS 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 UNIDENTIFIED SYMPTOMS OF HYPOGLYCEMIA ABOUT THREE AND A HALF HOURS AFTER THE ALLEGED METER ISSUE BEGAN. IT IS NOT CLEAR AS TO WHAT SPECIFIC SYMPTOMS SHE HAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2865614

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening