BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRA

    MDR report key: 657230 · Received December 21, 2005

    Report

    Report Number
    2939301-2005-04794
    Event Type
    Malfunction
    Date Received
    December 21, 2005
    Report Date
    October 12, 2005
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE PT DESCRIBED FEELING INCOHERENT DUE TO EXTREME LOW BLOOD GLUCOSE. THERE IS NO INFORMATION ON WHAT THE BLOOD GLUCOSE READING WAS ON THE COMPANY METER. THE PT ATE FOOD AND/OR DRANK A BEVERAGE AND CONTACTED EMS. THE READING ON THE EMS'S METER WAS 25 MG/DL. SHE MENTIONED THAT HER BLOOD GLUCOSE WAS "READING WAS UP TO 60 POINTS HIGHER". NO FURTHER CLINICAL INFORMATION HAS BEEN PROVIDED. SHE HAD COMPARED HER METER TO AN OLD ACCUCHEDK METER SHE HAS AND THE READING VARIED FROM 3 POINTS TO 60 POINT DIFFERENCE. THE TEST STRIPS WERE IN GOOD CONDITION AND NOT EXPIRED. THE TECHNIQUE OF APPLYING BLOOD ON THE TEST STRIP WAS CORRECT. TEST STRIPS FELL WITHIN RANGE WITH THE CONTROL SOLUTION. CUSTOMER SERVICES SENT THE PT A NEW METER AND CONTROL SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA GLUCOSE MONITORING SYS/KIT CFR LIFESCAN, INC. NA 2578168

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN