BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1867938 · Received October 13, 2010

    Report

    Report Number
    1823260-2010-06096
    Event Type
    Malfunction
    Date Received
    October 13, 2010
    Date of Event
    September 17, 2010
    Report Date
    January 31, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN GERMANY. NO INFORMATION WAS PROVIDED FOR THE MOBILE SYSTEM. THE CUSTOMER SENT BACK 2 LOT NUMBERS OF STRIPS, 202364 AND 202575. UNABLE TO DETERMINE WHICH ONE WAS USED AT THE TIME OF THE EVENT.

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). NO INFORMATION WAS PROVIDED FOR THE MOBILE SYSTEM.

    Description of Event or Problem · 1

    CALLER REPORTED 70 MG/DL ON THE MOBILE METER AND 40 MG/DL ON AVIVA COMBO METER AT THE SAME TIME. REPORTED NO ADVERSE EVENT RELATIVE TO DISCREPANCY. STRIPS LOT UNKNOWN. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT SENT.

    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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1