BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1971667 · Received January 27, 2011

    Report

    Report Number
    1823260-2011-00459
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    January 18, 2011
    Report Date
    February 18, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 2. (B)(6).

    Description of Event or Problem · 1

    REPORTER ALLEGED THE CUSTOMER RECEIVED A RESULT OF 174 MG/DL ON AVIVA SYSTEM 1 COMPARED BACK TO BACK WITH A RESULT OF 67 MG/DL ON AVIVA SYSTEM 2 WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES. REPORTER STATED THAT SHE TREATED THE CUSTOMER WITH JUICE AFTER OBTAINING THE READINGS. 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 302927

    Patients

    Seq Age Sex Outcome Treatment
    1 006 YR XOPENEX (AS NEEDED)| HUMALOG| EPIPEN (AS NEEDED)| LANTUS