BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRA

    MDR report key: 808644 · Received November 19, 2004

    Report

    Report Number
    2939301-2004-05895
    Event Type
    Malfunction
    Date Received
    November 19, 2004
    Report Date
    November 15, 2004
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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 NOVEMBER 15, 2004, THE PATIENT CONTACTED LIFESCAN ALLEGING THAT HIS ONE TOUCH ULTRA METER WAS READING INACCURATELY HIGH. THE PATIENT REPORTED THAT HE OBTAINED A 112, 119, 122, 118, 77, 92, 140, AND 115 MG/DL. HE HAD BEEN OBTAINING RESULTS BETWEEN 88 MG/DL AND 112 MG/DL DURING THE PREVIOUS MONTH. DURING ANOTHER OCCASION, THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF 114 MG/DL AND 149 MG/DL WITH THE LIFESCAN METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. THE PATIENT REPORTED VISITING HIS CARDIOLOGIST AND BEING REFERRED TO HIS PRIMARY CARE PHYSICIAN. NO TREATMENT WAS RECEIVED. THE PATIENT NEITHER ALLEGED HARM NOR EXPERIENCED INJURY OR MEDICAL INTERVENTION DURING THE TIME OF CONCERN. PATIENT'S DIABETES MEDICATION INCLUDE AVADIA AND GLUCOVANCE. THE CUSTOMER CARE REPRESENTATIVE DISCOVERED THROUGH TROUBLESHOOTING THAT TWO TEST STRIPS PEELED. PEELING TEST STRIPS ARE ATTRIBUTED BY THE USER TECHNIQUE AT THE TIME OF INSERTION INTO THE TEST STRIP PORT. NO FURTHER TROUBLESHOOTING WAS PERFORMED. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE BETWEEN 114 MG/DL AND 149 MG/DL EXCEEDS THE EXPECTED VALUE OF <=20% AND/OR<=20 MG/DL, THEREBY INDICATING A POTENTIAL MALFUNCTION OF THE METER IN TERMS OF PRECISION. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2515161

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR