BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 2882433 · Received December 20, 2012

    Report

    Report Number
    1823260-2012-06462
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 29, 2012
    Report Date
    February 1, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. (B)(4).

    Description of Event or Problem · 1

    CALLER REPORTED A NEONATE PATIENT WAS TESTED ON AVIVA SYSTEM 1 TWICE AT 8:05 AM, RESULTS WERE 26 MG/DL AND 35 MG/DL. CALLER STATES THAT AT 8:15 AM, A HEEL STICK SAMPLE WAS OBTAINED BY LAB. CALLER STATES THE HEEL STICK SAMPLE WAS TESTED ON AVIVA SYSTEM 2, RESULT WAS 49 MG/DL. CALLER STATES THAT THE SAME HEEL STICK SAMPLE WAS ANALYZED IN LAB, RESULT WAS 50 MG/DL. CALLER STATES THAT THE SAME VIAL OF STRIPS WERE USED TO PERFORM ALL METER TESTS. NO ADVERSE EVENT WAS REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS.

    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 303528

    Patients

    Seq Age Sex Outcome Treatment
    1 001 DA (B)(6)| ERYTHROMYCIN EYE DROPS| UNSPECIFIED IV| VITAMIN K