BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1823009 · Received September 1, 2010

    Report

    Report Number
    1823260-2010-05199
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    August 30, 2010
    Report Date
    September 16, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    THE USER RECEIVED COMPLAINTS FROM DOCTORS CONCERNING TSH (THYROID STIMULATING HORMONE) RESULTS WHICH DO NOT CORRELATE WITH THE DIAGNOSIS AND CLINICAL SIGNS OF THE PATIENT. THE DOCTORS CONSIDERED THE RESULTS FROM THE ANALYTICAL E MODULE TO BE HIGH. NO SPECIFIC PATIENT DATA WAS PROVIDED. THE USER PERFORMED A COMPARISON BETWEEN THE ANALYTICAL E MODULE ANALYZER AND THE ABBOTT ARCHITECT USING 40 PATIENT SAMPLES. OF THE PROVIDED DATA, THE RESULTS FOR TWO SAMPLES WERE DISCREPANT. NO UNITS OF MEASURE WERE PROVIDED. SAMPLE 1 RESULT FROM THE ANALYTICAL E MODULE WAS 6.59 AND RESULT FROM THE ABBOTT ARCHITECT WAS 4.94. ON (B)(6) 2010, SAMPLE 2 RESULT FROM THE ANALYTICAL E MODULE WAS 6.42 AND RESULT FROM THE ABBOTT ARCHITECT WAS 4.76. NO ADVERSE EVENTS WERE ALLEGED REGARDING THE DISCREPANCIES. THE LOT NUMBER OF THE TSH REAGENT WAS NOT PROVIDED.

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING THE RESULTS OF 556 MG/DL, 328 MG/DL AND 189 MG/DL BACK TO BACK WITHIN 10 MINUTES ON THE AVIVA SYSTEM. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 302714

    Patients

    Seq Age Sex Outcome Treatment
    1 046 YR