BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1221859 · Received November 3, 2008

    Report

    Report Number
    2939301-2008-02917
    Event Type
    Injury
    Date Received
    November 3, 2008
    Report Date
    October 27, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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/PT'S SPOUSE CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PT'S ONE TOUCH ULTRA METER WAS READING INACCURATELY. IN ADDITION, THE PT'S SPOUSE REPORTED THAT THE SUBJECT METER WAS NOT DISPLAYING A CODE NUMBER. THE MEDICAL AFFAIRS SPECIALIST (MAS) SPOKE WITH THE PT ON FIVE DAYS LATER AND OBTAINED THE FOLLOWING INFO. THE PT WAS UNABLE TO CONFIRM WHEN HER HUSBAND FIRST NOTICED THAT THE SUBJECT METER WAS ALLEGEDLY NOT DISPLAYING A CODE NUMBER; HOWEVER, STATED THAT SHE BEGAN TO OBTAIN INACCURATE HIGH READING APPROX 3 WEEKS PRIOR TO CONTACTING LFS. ON THE EVENING OF SIX DAYS PRIOR TO ORIGINAL DATE, THE PT STATED THAT SHE OBTAINED A READING OF "271 MG/DL" WITH THE SUBJECT METER. AS A RESULT OF THE READING, THE PT REPORTED THAT SHE TOOK 2 UNITS OF HUMALOG INSULIN BASED ON HER SLIDING SCALE. WITHIN 1 HOUR OF TAKING THE 2 UNITS OF HUMALOG, THE PT CLAIMED SHE BECAME DIZZY, TIRED AND EXTREMELY SWEATY. THE PT CONFIRMED THAT SHE DID TEST WITH THE SUBJECT METER AT THE TIME OF THE SYMPTOMS, BUT DID NOT RECALL THE READING OBTAINED. HOWEVER, THE PT DID RECALL THAT SHE OBTAINED A RESULT OF "41 MG/DL" WITH HER SPOUSE'S NON-LFS METER AT THE SAME TIME. THE PT REPORTED THAT SHE TREATED SELF WITH JUICE AND CANDY AND FELT BETTER AFTERWARDS. AT THE TIME OF TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE (CCA) CONFIRMED THAT THE SUBJECT METER WAS DISPLAYING A CODE NUMBER AS EXPECTED; HOWEVER, DISCOVERED THAT THE CODE NUMBER ON THE METER DID NOT MATCH THE CODE NUMBER OF THE TEST STRIPS IN USE. THE CCA WAS ABLE TO WALK THE REPORTER THROUGH SUCCESSFULLY CHANGING THE CODE NUMBER. THE CODE ISSUE WAS RESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT CLAIMS SHE OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULT, AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2860461

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Life Threatening| R