BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1475036 · Received September 15, 2009

    Report

    Report Number
    2939301-2009-05696
    Event Type
    Injury
    Date Received
    September 15, 2009
    Date of Event
    July 19, 2009
    Report Date
    August 30, 2009
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVAL. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM, AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON AUGUST 30, 2009, THE LAY USER/PT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRA METER WAS PROMPTING AN "ER 5" MESSAGE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION, SINCE THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE PT BY PHONE. THE PT REPORTED THAT THE ALLEGED ERROR MESSAGE BEGAN TO APPEAR IN 2009. PER THE ONETOUCH ULTRA OWNER'S BOOKLET, THIS ERROR INDICATES THAT THE METER HAS DETECTED A PROBLEM WITH THE TEST STRIP. THE CCA NOTED THAT THE PT MANAGES HIS DIABETES WITH INSULIN (SELF-ADJUSTER); HOWEVER, IT IS NOT KNOWN WHAT ACTION THE PT TOOK REGARDING HIS DIABETES MANAGEMENT AS A RESULT OF THE ALLEGED ISSUE. SOMETIME AFTER THE ISSUE STARTED, THE PT CLAIMED HE BEGAN TO FEEL DISORIENTED, DIZZY AND ALSO REPORTED "BLACKING OUT." THE PT REPORTED THAT AT ABOUT 2 DAYS LATER, HE WAS HOSPITALIZED AND TREATED WITH POTASSIUM. IT IS NOT KNOWN IF THE PT'S TREATMENT WAS IN RESPONSE TO A LOW OR HIGH GLUCOSE. THE PT STATED THAT HE OBTAINED READINGS OF "120-174 MG/DL" WHEN TESTED ON THE ER/HOSPITAL METER. IT IS NOT KNOWN IF THESE RESULTS WERE OBTAINED PRIOR TO OR AFTER TREATMENT. IN THE NEXT DAY, AFTER BEING DISCHARGED FROM THE HOSPITAL, THE PT STATED THAT HE TOOK A DECREASED DOSE OF INSULIN (30 UNITS OF UNSPECIFIED TYPE). AT THE TIME OF TROUBLESHOOTING THE CCA NOTED THAT THE PT WAS USING THE CORRECT TESTING TECHNIQUE AND THE SUBJECT STRIPS APPEARED IN GOOD CONDITION. THE ERROR MESSAGE WAS RESOLVED WHEN THE PT RETESTED WITH A NEW VIAL OF TEST STRIPS. REPLACEMENT PRODUCTS WERE SENT TO THE PT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT CLAIMS HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY "BLACKED OUT" 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 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| L| R