BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 2890831 · Received December 31, 2012

    Report

    Report Number
    1823260-2012-06602
    Event Type
    Malfunction
    Date Received
    December 31, 2012
    Date of Event
    December 2, 2012
    Report Date
    January 7, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K101299
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 IS FOR THE AVIVA SYSTEM 1. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER ALLEGEDLY RECEIVED THE FOLLOWING RESULTS, WITH TWO DIFFERENT METERS: AVIVA SYSTEM 1: 88 MG/DL AT 1100, 77 MG/DL AT 1118, 204 MG/DL AT 1120, 97 MG/DL AT 1122. AVIVA SYSTEM 2: 93 MG/DL AT 1059, 547 MG/DL AT 1103, 56 MG/DL AT 1116. READINGS WERE ALL TAKEN ON THE SAME DAY. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND STRIPS, AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 491319

    Patients

    Seq Age Sex Outcome Treatment
    1 073 YR LANTUS| NOVOLOG