BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRA

    MDR report key: 564396 · Received May 18, 2004

    Report

    Report Number
    2939301-2004-03189
    Event Type
    Malfunction
    Date Received
    May 18, 2004
    Report Date
    May 11, 2004
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT MENTIONED THAT THEY DID A METER TO LAB COMPARISON AND THE RESULTS EXCEEDS LIFESCAN'S CRITERIA FOR ACCURACY. THEY HAD DONE SEVERAL READINGS ON THE LFS METER, NO INFORMATION ON WHICH READINGS THEY COMPARED TO THE LAB. READINGS THEY OBTAINED ON THE LFS METER WERE: 262, 263, 329, 184, 193, 115, 321, 309, 225, 242, 225, 271, 242 AND 216 MG/DL. LAB RESULT WAS 158 MG/DL DONE LESS THAN 10 MINUTES FROM THEIR METER READINGS. BETWEEN THE TESTS THERE WAS NO INTERVENTION THAT WOULD BE EXPECTED TO CHANGE THE BLOOD GLUCOSE. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS, EXCEPT FOR THE READING OF THE 184 MG/DL, EXCEEDS LIFESCAN'S CRITERIA FOR ACCURACY. THE TECHNIQUE OF APPLYING BLOOD ON THE TEST WAS DONE CORRECTLY. TEST STRIPS WERE IN GOOD CONDITION AND NOT EXPIRED CONTROL SOLUTION TEST WAS DONE TWICE AND IT FAILED BOTH TIMES. CUSTOMER SERVICE WAS UNABLE TO RESOLVE THE ISSUE AND IS SENDING PATIENT NEW VIAL OF TEST STRIPS. THIS CASE IS BEING REPORTED AS A MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA GLUCOSE MONITORING SYS/KIT CFR LIFESCAN, INC. NA 1024062

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN