BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1841672 · Received September 22, 2010

    Report

    Report Number
    1823260-2010-05635
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    September 10, 2010
    Report Date
    September 29, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS POLY WEAR, OSTEOLYSIS, AND LOOSENING OF THE FEMORAL, TIBIAL, AND PATELLAR COMPONENTS AT THE CEMENT/IMPLANT INTERFACE (COMPETITOR'S CEMENT WAS USED IN THE PRIMARY SURGERY).

    Description of Event or Problem · 1

    REPORTER ALLEGED THE CUSTOMER OBTAINED THE RESULTS OF 240 MG/DL AND 97 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 302608

    Patients

    Seq Age Sex Outcome Treatment
    1 078 YR