BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRAMINI METER

    MDR report key: 1221861 · Received November 3, 2008

    Report

    Report Number
    2939301-2008-02914
    Event Type
    Injury
    Date Received
    November 3, 2008
    Date of Event
    October 18, 2008
    Report Date
    October 19, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVAL, BUT HAS NOT YET RECEIVED THEM. IF EITHER THE METER OR STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE IT/THEM AND, IF EITHER THE METER OR STRIPS 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'S/PATIENT'S COUSIN (REPORTER) CONTACTED LIFESCAN (LFS) ALLEGING AN APPLY SAMPLE ISSUE WITH THE ONETOUCH ULTRAMINI METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE'S (CCA) DOCUMENTATION SINCE THE MEDICAL AFFAIRS SPECIALIST (MAS) WAS UNABLE TO GATHER ADDITIONAL INFO FROM THE CUSTOMER. THE REPORTER STATED THAT THE ALLEGED ISSUE BEGAN ON THE SAME DAY APPROX AT 8PM. DURING THAT TIME, THE PT REPORTEDLY HAD AN APPLY SAMPLE ISSUE WITH THE SUBJECT METER. IT IS NOT KNOWN WHETHER THE PT WAS ABLE TO GET ANY BLOOD GLUCOSE READINGS BEFORE, DURING OR AFTER THE REPORTED ISSUE. AT AN UNSPECIFIED TIME, AFTER THE REPORTED ISSUE, THE PT REPORTEDLY EXPERIENCED SYMPTOMS OF "INSULIN SHOCK." IT IS NOT KNOWN WHETHER THE PT OBTAINED ANY READINGS ON THE SUBJECT METER WHILE EXPERIENCING THE SYMPTOMS. THE PT REPORTEDLY TOOK NO DIABETES TREATMENT ACTIONS FOLLOWING THE ISSUE AND DID NOT RECEIVE/REQUIRE ANY MEDICAL TREATMENT OR INTERVENTION FOR THE DIABETES. THE PT WAS NOT TESTED ON ANY OTHER METER. DURING THE TROUBLESHOOTING, THE CCA NOTED THAT THE PT WAS ACCESSING THE MEMORY MODE WHEN PERFORMING A BLOOD TEST. THE CCA ASSISTED THE CUSTOMER ON HOW TO INSERT A TEST STRIP AND HOW TO PROPERLY PERFORM A BLOOD TEST. THE REPORTED ISSUE WAS RESOLVED DURING THE TROUBLESHOOTING. THERE IS NO EVIDENCE INDICATIVE OF A METER MALFUNCTION SINCE IT WAS NOTED THAT THE REPORTED ISSUE WAS RESOLVED DURING THE TROUBLESHOOTING. THIS COMPLAINT IS BEING REPORTED SINCE THE PT ALLEGEDLY EXPERIENCED SYMPTOMS THAT COULD BE SUGGESTIVE OF A HYPOGLYCEMIC EPISODE AFTER THE REPORTED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2807310

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Life Threatening