BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 2901414 · Received January 8, 2013

    Report

    Report Number
    1823260-2013-00156
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    December 23, 2012
    Report Date
    February 28, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. (B)(4). IT WAS REPORTED THAT PATIENT WAS (B)(6). THE BIRTHDATE GIVEN WAS AN ESTIMATE AND NOT THE ACTUAL DATE OF BIRTH.

    Description of Event or Problem · 1

    CALLER REPORTED INFORM SYSTEM BLOOD GLUCOSE RESULTS OF 282 MG/DL WITH INFORM SYSTEM 1 AND 86 MG/DL WITH INFORM SYSTEM 2 WITHIN 10 MINUTES. NO ADVERSE EVENT WAS REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE STRIPS, REPLACEMENT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8836 ACCU-CHEK ® COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 551829

    Patients

    Seq Age Sex Outcome Treatment
    1 058 YR NOVOLOG IV DRIP