BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® INFORM II TEST STRIPS

    MDR report key: 3894838 · Received June 25, 2014

    Report

    Report Number
    1823260-2014-04660
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    May 28, 2014
    Report Date
    August 8, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K121679
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. STRIPS NOT AVAILABLE FOR RETURN.

    Description of Event or Problem · 1

    AT 9:42 PM, A RESULT FROM THIS INFORM II METER WAS 465 MG/DL. AT 9:50 PM, A RESULT FROM THIS METER WAS 150 MG/DL. AT 10:05 PM, A LAB DRAW WAS PERFORMED, THE RESULT WAS 103 MG/DL. NO ADVERSE EVENT WAS REPORTED. STRIPS ARE NOT AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370145 ACCU-CHEK ® INFORM II TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 471639

    Patients

    Seq Age Sex Outcome Treatment
    1 087 YR