BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRA

    MDR report key: 657821 · Received December 21, 2005

    Report

    Report Number
    2939301-2005-04687
    Event Type
    Malfunction
    Date Received
    December 21, 2005
    Report Date
    October 14, 2005
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE LAY REPORTER CONTACTED LIFESCAN ON BEHALF OF THE LAY USER/PATIENT IN 05 ALLEGING THAT THE PATIENT'S TEST STRIPS WERE DAMAGED. THE MEDICAL AFFAIRS SPECIALIST (MAS) MAILED A LETTER THREE DAYS LATER SINCE THE PATIENT COULD NOT BE REACHED BY TELEPHONE FOR FURTHER CLARIFICATION. THE LAY REPORTER MENTIONED THAT THE PATIENT RECEIVED AN ERROR 4 MESSAGE ON THE LIFESCAN (LFS) METER. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS AT THE TIME OF TESTING. THE PATIENT TESTED ON SOMEONE ELSE'S METER AND RECEIVED A 298 MG/DL. (THERE WAS A 15-20 MINUTE DIFFERENCE BETWEEN THE TWO TESTS). THE PATIENT CONTACTED EMS AND WHEN THE PATIENT WAS TESTED ON THE EMT'S METER HER READING WAS A 116 MG/DL. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. IT WOULD HAVE BEEN HELPFUL TO KNOW THE PATIENT'S DIABETES REGIMEN, WHOSE METER THE PATIENT RECEIVED THE 298 MG/DL AND HOW LONG SHE WAS UNABLE TO OBTAIN A READING ON THE ULTRA METER. THE LAY REPORTER WAS UNABLE/UNWILLING TO VERIFY HOW LONG THE TEST STRIPS HAD BEEN OPENED AND HOW OFTEN THE PATIENT DOES QUALITY CONTROL. THE LAY REPORTER DID MENTION THAT TEST STRIPS HAD BUBBLES ALONG THE EDGES. CUSTOMER CARE AGENT (CCA) SENT THE PATIENT A REPLACEMENT METER AND TEST STRIPS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN