BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH BASIC ENHANCED METER

    MDR report key: 1032812 · Received April 21, 2008

    Report

    Report Number
    2939301-2008-00603
    Event Type
    Injury
    Date Received
    April 21, 2008
    Report Date
    April 4, 2008
    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 HAS REQUESTED THE RETURN OF THE SUBJECT METER, TEST STRIPS, AND CONTROL SOLUTION FOR EVALUATION, BUT HAS NOT YET RECEIVED THEM. IF EITHER THE METER, STRIPS, AND/OR CONTROL SOLUTIONS ARE RETURNED, LIFESCAN WILL EVALUATE THEM AND, IF EITHER THE METER, STRIPS, OR CONTROL SOLUTION DO NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IN 2008, THE LAY-USER/REPORTER CONTACTED LIFESCAN ALLEGING THAT A ONE TOUCH BASIC METER HAD A MISSING SEGMENTS ISSUE. THE PT TESTS HER BLOOD GLUCOSE 2 TIMES A DAY. SHE MANAGES HER DIABETES VIA PILLS, DIET, AND/OR EXERCISE. THE REPORTER DID NOT KNOW WHEN THE ALLEGED MISSING SEGMENTS ISSUE STARTED. DURING THE CALL WITH THE ONE TOUCH CUSTOMER ADVOCATE (OTCA), THE REPORTER MENTIONED THAT THE DEVICE WAS NOT GIVING READINGS. AS A RESULT OF THE REPORTED ISSUE, THE PT WAS TAKING EXTRA MEDICATION(S). ON AN UNSPECIFIED DATE/TIME AFTER THE ISSUE BEGAN, THE PT DEVELOPED SYMPTOMS OF FREQUENT URINATION AND FEELING THIRSTY. ON THE DAY BEFORE, THE PT WENT TO A CLINIC. HER BLOOD GLUCOSE WAS CHECKED ON AN UNIDENTIFIED DEVICE BUT THE REPORTER DID NOT KNOW WHAT RESULT WAS OBTAINED. THE REPORTER EXPLAINED THAT SHE WAS NOT THERE DURING THE VISIT TO THE CLINIC. IT IS NOT KNOWN IF THE PT RECEIVED ANY MEDICAL TREATMENT FROM THE CLINIC. IT WOULD HAVE BEEN HELPFUL TO KNOW THE FOLLOWING INFORMATION: WHEN THE REPORTED METER ISSUE BEGAN, IF THE PT TRIED TO INTERPRET HER METER READINGS WITH THE ALLEGED MISSING SEGMENTS, HER MEDICATION AND DIABETES MANAGEMENT REGIMENS, AND WHAT SPECIFIC ACTIONS THE PT TOOK IN RESPONSE TO THE REPORTED METER ISSUE. IN ADDITION, IT WOULD HAVE BEEN HELPFUL TO KNOW WHAT DATE/TIME THE SYMPTOMS DEVELOPED, WHAT ACTIONS THE PT TOOK BEFORE AND AFTER THE SYMPTOMS DEVELOPED, WHAT TREATMENT (IF ANY) SHE RECEIVED IN THE CLINIC, AND WHAT BLOOD GLUCOSE READING THE CLINIC OBTAINED. ACCORDING TO THE ONE TOUCH CUSTOMER ADVOCATE (OTCA), THE METER TO BE WORKING FINE DURING TROUBLESHOOTING. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE REPORTER CLAIMED THAT THE PT DEVELOPED SYMPTOMS SUGGESTIVE FOR HYPERGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN. IT IS NOT KNOWN WHAT DURATION OF TIME THE ALLEGED METER ISSUE HAD BEEN OCCURRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH BASIC ENHANCED METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2762718

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening