BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 761975 · Received September 12, 2006

    Report

    Report Number
    2939301-2006-01233
    Event Type
    Injury
    Date Received
    September 12, 2006
    Report Date
    September 1, 2006
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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

    ON SEPTEMBER 1, 2006, THE LAY-USER/REPORTER CONTACTED LIFESCAN ALLEGING THAT A ONE TOUCH ULTRA (OTU) METER WAS READING INACCURATELY HIGH. THE MEDICAL AFFAIRS SPECIALIST (MAS) SPOKE TO THE PATIENT ON SEPTEMBER 8, 2006, TO OBTAIN / VERIFY INFORMATION. STARTING 2006, THE PATIENT WAS IN A NURSING HOME. THE REPORTER STATES THE PATIENT HAD HYPOGLYCEMIC EPISODES EARLY IN THE MORNINGS. DURING EACH EPISODE, THE PATIENT WOULD BECOME SWEATY AND CONFUSED. THE PATIENT'S SYMPTOMS WOULD TYPICALLY BE TREATED BY GIVING HER ORANGE JUICE. THE REPORTER STATED THAT THE PATIENT WAS NEVER HOSPITALIZED DUE TO THESE EPISODES. THE NURSING HOME INFORMED THE REPORTER THAT THESE EPISODES WOULD ONLY OCCUR AFTER GIVING THE PATIENT A SLIDING-SCALE INSULIN DOSE BASED ON THE REPORTED METER'S RESULTS. WHENEVER THE NURSING HOME USED THEIR OWN UNIDENTIFIED METER, THE PATIENT WOULD NEVER HAVE AN INSULIN REACTION. THE NURSING HOME ALSO INFORMED THE REPORTER THAT THE OTU WOULD TYPICALLY READ 80-100 POINTS HIGHER THAN THEIR OWN METER. HOWEVER, IT IS NOT KNOWN HOW THE COMPARISONS BETWEEN THE TWO METERS WERE PERFORMED OR WHAT THE TIME DIFFERENCES WERE. THE REPORTER WAS ONLY ABLE TO PROVIDE READINGS OF "240, 226, 202, 187, AND 194 MG/DL" FROM THE METER'S MEMORY. IT IS NOT KNOWN WHEN THESE READINGS WERE TAKEN. SHE DID NOT KNOW WHAT READINGS THE PATIENT GOT DURING AND AFTER THE INSULIN REACTIONS. THE REPORTER ONLY KNOWS THAT THE PATIENT RECEIVES A SLIDING-SCALE DOSE OF INSULIN UP TO 3 TIMES PER DAY AND ONLY OCCURS WHEN HER BLOOD GLUCOSE IS ABOVE 150 MG/DL. SHE TAKES "HUMULIN 70/30" INSULIN TWICE A DAY. THE PATIENT ALSO TAKES "ACTOS." THE PATIENT INDICATED THAT THE REPORTED METER PASSED A CONTROL SOLUTION TEST. IT IS REPORTED THAT THE PATIENT HAS BEEN USING A CORRECT TECHNIQUE FOR TESTING WITH THE REPORTED METER. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT HAS SUFFERED SEVERAL POSSIBLE HYPOGLCYEMIC EPISODES AFTER RECEIVING SLIDING-SCALE INSULIN DOSAGES BASED ON THE REPORTED METER'S READINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2617381

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Life Threatening| R