BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 952647 · Received November 19, 2007

    Report

    Report Number
    2939301-2007-01395
    Event Type
    Injury
    Date Received
    November 19, 2007
    Date of Event
    November 8, 2007
    Report Date
    November 12, 2007
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    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 ON NOVEMBER 12, 2007 AND ALLEGED THAT HIS ONE TOUCH ULTRA METER WAS READING INACCURATE CONTROL HIGH. THE MEDICAL AFFAIRS SPECIALIST WAS UNABLE TO REACH THE PATIENT AFTER SEVERAL ATTEMPTS VIA PHONE TO OBTAIN FURTHER INFORMATION. A LETTER WAS SENT TO THE ADDRESS PROVIDED. THE PATIENT REPORTED, THAT THE ALLEGED ISSUE FIRST OCCURRED IN 2007 AT 2:30 PM. HE OBTAINED A RESULT OF 143 MG/DL WHEN PERFORMING A CONTROL SOLUTION TEST, WHICH FAILED HIGH OUTSIDE THE RANGE OF 102-136 MG/DL. SINCE THE CONTROL TEST FAILED, PER THE OWNER'S MANUAL, IT IS RECOMMENDED TO NOT USE THE SYSTEM TO TEST THE BLOOD GLUCOSE AND THEREFORE, THE PATIENT WAS ABLE TO TEST ON THAT METER. HE THEN ATTEMPTED TO USE ANOTHER METER, WHICH ALSO READ THE CONTROL SOLUTION HIGH OUTSIDE THE RANGE. WHILE ATTEMPTING TO RESOLVE THE CONTROL SOLUTION HIGH ISSUE, HE WAS LATE IN EATING HIS SNACK AND STATED THAT, HE STARTED FEELING SHAKY AND TREATED SELF WITH ORANGE JUICE. AT THE TIME OF TROUBLESHOOTING, IT WAS VERIFIED THAT THE METER WAS SET IN THE RIGHT UNIT OF MEASUREMENT (MG/DL) AND THAT IT WAS CODED CORRECTLY. THE CONTROL SOLUTION AND TEST STRIPS WERE IN GOOD CONDITION AND WITHIN THE EXPIRATION/DISCARD DATES. THE PATIENT'S TESTING TECHNIQUE WAS REVIEWED TO BE CORRECT. HOWEVER, THE ISSUE WAS NOT RESOLVED WHEN THE PATIENT WAS WALKED THROUGH ANOTHER CONTROL SOLUTION TEST. ALTHOUGH TREATMENT IS NOT TO BE BASED ON CONTROL SOLUTION RESULTS AND THERE IS NO ALLEGATION OF INACCURACY OF THE BLOOD GLUCOSE RESULTS, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT STATED WHILE ATTEMPTING TO RESOLVE THE ALLEGED ISSUE, HE WAS LATE IN EATING HIS SNACK AND DEVELOPED SYMPTOM SUGGESTIVE OF HYPOGLYCEMIA, WHICH HE TREATED WITH JUICE. 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 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2739530

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Life Threatening