BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRAMINI METER

    MDR report key: 1222069 · Received November 4, 2008

    Report

    Report Number
    2939301-2008-02927
    Event Type
    Injury
    Date Received
    November 4, 2008
    Date of Event
    October 21, 2008
    Report Date
    October 22, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVALUATION, 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

    THE LAY USER/PATIENT CONTACTED LIFESCAN IN 2008, AND ALLEGED THAT HER ONE TOUCH ULTRAMINI METER WAS NOT POWERING ON. THE MEDICAL AFFAIRS SPECIALIST WAS UNABLE TO REACH THE PATIENT AFTER SEVERAL ATTEMPTS VIA PHONE. A LETTER WAS SENT TO THE ADDRESS PROVIDED. THE PATIENT REPORTED THAT THE ALLEGED ISSUE FIRST OCCURRED ONE DAY PRIOR. AS A RESULT OF THE REPORTED ISSUE, SHE INCREASED HER REGULAR INSULIN BY 10 EXTRA UNITS. THE PATIENT REPORTED THAT SHE DEVELOPED SYMPTOMS OF BEING WEAK AND SWEATY AFTER THE REPORTED ISSUE BEGAN. SHE WAS TESTED ON THE VISITING NURSE'S METER AND REPORTEDLY OBTAINED A RESULT OF 47 MG/DL. THE PATIENT WAS GIVEN FOOD BY THE NURSE. AT THE TIME OF TROUBLESHOOTING, IT WAS VERIFIED THAT THIS WAS NOT A NEW PRODUCT. BASED ON THE INFORMATION PROVIDED, THERE IS NO MISUSE OF THE METER. THE PATIENT HAD REPLACED THE BATTERY PER THE OWNER'S MANUAL AND THE BATTERY WAS CORRECTLY INSTALLED. THE CONDITION OF THE BATTERY CONTACTS WAS ALSO GOOD. THE METER DID NOT TURN ON WHEN THE POWER BUTTON WAS PRESSED OR WHEN THE TEST STRIP WAS INSERTED ALL THE WAY INTO THE TEST STRIP PORT. THE PATIENT WAS USING THE CORRECT TEST STRIPS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA DUE TO TAKING EXTRA INSULIN. AFTER THE REPORTED ISSUE BEGAN. SHE WAS TREATED WITH FOOD BY THE VISITING NURSE. THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. REPLACEMENT PRODUCTS WERE SENT TO THE LAY USER/PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2797679

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Life Threatening