BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1984163 · Received February 10, 2011

    Report

    Report Number
    1823260-2011-00767
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    January 26, 2011
    Report Date
    March 2, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    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.

    Description of Event or Problem · 1

    INFORM USER FACILITY REPORTED PATIENT BLOOD GLUCOSE RESULTS OF 48 MG/DL AT 11:39, 265 MG/DL AT 11:42. LAB RESULT FROM SAMPLE DRAWN AT 12:00 WAS 266 MG/DL. CALLER REPORTED SHE RAN THE LAB SPECIMEN ON THIS METER TO CHECK IT OUT AND THE RESULTS MATCH THE ORIGINAL LAB VALUE. CONTROLS ARE RUN DAILY AND BOTH LEVELS PASSED THIS MORNING. REPORTED NO ADVERSE EVENT. A REQUEST WAS MADE FOR THE RETURN OF THE STRIPS.

    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 551342

    Patients

    Seq Age Sex Outcome Treatment
    1 063 YR TYLENOL| LANTUS| GENTAMICIN| VITAMIN C