BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 2110970 · Received June 2, 2011

    Report

    Report Number
    1823260-2011-02924
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 4, 2011
    Report Date
    July 27, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    REPORTER ALLEGED THAT A PATIENT RECEIVED THE RESULT OF 43 MG/DL ON THE INFORM SYSTEM COMPARED BACK TO BACK WITHIN 10 MINUTES OF A RESULT OF 229 MG/DL OBTAINED ON A LAB SYSTEM. REPORTER STATED THAT THE PATIENT WAS TREATED PRIOR TO THE LAB BLOOD DRAW. THE TREATMENT WAS UNSPECIFIED. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT. REPORTER STATED THAT THE STRIPS WERE ALL USED, SO NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 551402

    Patients

    Seq Age Sex Outcome Treatment
    1