BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1060333 · Received June 13, 2008

    Report

    Report Number
    2939301-2008-01088
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    June 3, 2008
    Report Date
    June 3, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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

    IN 2008, THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING APPLY SAMPLE METER ISSUE WITH ONETOUCH ULTRA2 METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CASE ADVOCATE (CCA) DOCUMENTATION. THE MEDICAL AFFAIRS SPECIALIST (MAS) WAS UNABLE TO CORRESPOND WITH THE PATIENT BY PHONE. THE MAS MAILED A LETTER TO THE PATIENT ON JUNE 11, 2008. THE PATIENT TESTS HER BLOOD GLUCOSE 4 TIMES A DAY. HE MANAGES HIS DIABETES VIA LANTUS ONCE A DAY AND HUMALOG BASED ON A SLIDING SCALE. THE PATIENT STATED THAT THE ALLEGED METER ISSUE BEGAN ON ORIGINAL DATE AT 10:30AM. AS A RESULT OF THE REPORTED ISSUE AT AN UNKNOWN TIME, THE PATIENT REPORTEDLY TOOK HUMALOG 12 UNITS ON A SLIDING SCALE. AT AN UNSPECIFIED TIME, THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS OF "FEELING HIGH". THE PATIENT DID NOT RECEIVE/REQUIRE ANY MEDICAL TREATMENT FOR THE DIABETES. HE WAS NOT TESTED ON ANY OTHER METER. DURING THE TROUBLESHOOTING, THE CCA FOUND OUT THAT THE PATIENT WAS USING THE CORRECTIVE TECHNIQUE FOR SAMPLE APPLICATION, THE TEST STRIP DRAW THE SAMPLE INTO THE TEST AREA AND THE ISSUE WAS NOT RESOLVED WHEN RETESTED WITH A NEW VIAL OF TEST STRIPS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY EXPERIENCED SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2822148

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening