BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 2213091 · Received August 16, 2011

    Report

    Report Number
    1823260-2011-04369
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 29, 2011
    Report Date
    August 19, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED THAT ON (B)(6) 2011, THE CUSTOMER OBTAINED THE RESULTS OF 207 MG/DL AND 70 MG/DL BACK TO BACK WITHIN 10 MINUTES ON THE AVIVA SYSTEM. REPORTER ALSO ALLEGED THAT ON (B)(6) 2011, THE CUSTOMER OBTAINED THE RESULTS OF 332 MG/DL AND 112 MG/DL BACK TO BACK WITHIN 10 MINUTES ON THE SAME AVIVA SYSTEM. THE CUSTOMER SELF-TREATED WITH A GLUCOSE TABLET AFTER THE SECOND COMPARISON. NO OTHER 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 303114

    Patients

    Seq Age Sex Outcome Treatment
    1 019 YR LANTUS| HUMALOG