BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1834614 · Received September 15, 2010

    Report

    Report Number
    1823260-2010-05450
    Event Type
    Malfunction
    Date Received
    September 15, 2010
    Date of Event
    September 6, 2010
    Report Date
    September 23, 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

    CALLER REPORTED BLOOD GLUCOSE RESULTS OF 329 MG/DL AND 143 MG/DL WITHIN 10 MINUTES ON THE AVIVA SYSTEM. REPORTED A SECOND, SEPARATE COMPARISON OF BLOOD GLUCOSE RESULTS OF 399 MG/DL AND 102 MG/DL WITHIN 10 MINUTES ON THE SAME SYSTEM. REPORTED NO ADVERSE EVENT RELATIVE TO DISCREPANCY. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT SENT.

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "NO HARM/INJURY REPORTED" (NO CONSEQUENCES OR IMPACT TO PATIENT). PRODUCT PROBLEM(S): "CASSETTE FAILED TO CONNECT" (FAILURE TO PRIME); THE CUSTOMER REPORTED: THE CASSETTE FAILED TO CONNECT TO THE SYSTEM. NO PATIENT IMPACT WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    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 302366

    Patients

    Seq Age Sex Outcome Treatment
    1 049 YR