BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 2875095 · Received December 17, 2012

    Report

    Report Number
    1823260-2012-06338
    Event Type
    Malfunction
    Date Received
    December 17, 2012
    Date of Event
    November 18, 2012
    Report Date
    January 25, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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

    CALLER STATES THAT A PATIENT REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON A METER, COMPARED TO LAB RESULTS WITHIN 10 MINUTES: 123 MG/DL (INFORM METER) AND 450 MG/DL (LAB). NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT STRIPS AND REPLACEMENT WAS SENT.

    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 551745

    Patients

    Seq Age Sex Outcome Treatment
    1 037 YR HUMALOG| PERIPHERALLY INSERTED CENTRAL CATHETER