BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 2032554 · Received March 29, 2011

    Report

    Report Number
    1823260-2011-01667
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    March 15, 2011
    Report Date
    April 4, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. THIS MEDWATCH REPORT IS FOR THE AVIVA SUSPECT SYSTEM USED. REFERENCE MEDWATCH REPORT WITH PATIENT IDENTIFIER (B)(6) FOR THE ADVANTAGE SUSPECT SYSTEM USED.

    Description of Event or Problem · 1

    REPORTER ALLEGED THE CUSTOMER RECEIVED THE RESULTS OF 360 MG/DL AND 399 MG/DL ON THE ADVANTAGE SYSTEM COMPARED BACK TO BACK WITH A RESULT OF 108 MG/DL ON THE AVIVA SYSTEM WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES. 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 302317

    Patients

    Seq Age Sex Outcome Treatment
    1 068 YR METFORMIN| BLOOD PRESSURE METER| GLUCOPHAGE