BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 2434697 · Received February 1, 2012

    Report

    Report Number
    1823260-2012-00571
    Event Type
    Malfunction
    Date Received
    February 1, 2012
    Date of Event
    January 16, 2012
    Report Date
    January 30, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. MEDWATCH (B)(6) IS FOR INFORM SYSTEM 1, MEDWATCH (B)(6) IS FOR INFORM SYSTEM 2.

    Description of Event or Problem · 1

    CALLER REPORTED BLOOD GLUCOSE RESULTS OF 29 MG/DL ON INFORM SYSTEM 1, 140 MG/DL ON INFORM SYSTEM 2 WITHIN 10 MINUTES. LAB SAMPLE WAS DRAWN, ALSO WITHIN 10 MINUTES OF THE ORIGINAL READING. EXACT LAB RESULT IS UNKNOWN; FLOOR STAFF REPORTS ONLY THAT THE RESULT CORRESPONDED TO THE 140 MG/DL. NO ADVERSE EVENT WAS REPORTED. 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 551563

    Patients

    Seq Age Sex Outcome Treatment
    1