BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 717979 · Received May 19, 2006

    Report

    Report Number
    2939301-2006-00725
    Event Type
    Injury
    Date Received
    May 19, 2006
    Date of Event
    May 7, 2006
    Report Date
    May 7, 2006
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE LAY USER/REPORTER CALLED LIFESCAN (LFS) ON THE DATE OF EVENT AND ALLEGED THAT THE PATIENT'S METER WAS READING INACCURATELY HIGH. THE MEDICAL AFFAIRS SPECIALIST SPOKE TO THE PATIENT THE NEXT DAY AND OBTAINED AND VERIFIED THE FOLLOWING INFORMATION. THE PATIENT REPORTED THAT FOR THE PAST 4 DAYS, HE HAS BEEN OBTAINING RESULTS THAT HE FELT WERE HIGHER THAN NORMAL. SOME OF THE RESULTS WERE 161, 191, 168, AND 217 MG/DL. THE PATIENT TAKES A SET AMOUNT OF LANTUS, BUT HIS HUMALOG INSULIN IS BASED ON A SLIDING SCALE. HE HAD INCREASED HIS HUMALOG BASED ON THE HIGHER READINGS. HE NOTICED THAT ABOUT 20 MINUTES AFTER TAKING HIS INSULIN, HE BEGAN TO FEEL SWEATY, SHAKY, AND "JUST NOT FEELING WELL". HE STATED THAT HE REALIZED HE WAS BECOMING LOW, SO HE HAD SOMETHING TO EAT AND DRINK AND THEN BEGAN TO DECREASE THE AMOUNT OF INSULIN HE WAS TAKING. HE DID NOT SEEK ANY MEDICAL ATTENTION. THE TESTING SUPPLIES WERE IN GOOD CONDITION, STORED PROPERLY, AND NOT EXPIRE, THE TESTING TECHNIQUE WAS CORRECT AND THE TECHNIQUE FOR CLEANING THE PUNCTURE SITE WAS CORRECT. THE PATIENT DID NOT HAVE CONTROL SOLUTION TO TROUBLESHOOT. THIS COMPLAINT IS BEING REPORTED AS PATIENT WAS EXHIBITING SYMPTOMS OF LOW BLOOD GLUCOSE AFTER TAKING INSULIN, WHICH WAS BASED ON HIS METER RESULTS. A REPLACEMENT METER HAS BEEN SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2577742

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Life Threatening| R