BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 2062840 · Received April 19, 2011

    Report

    Report Number
    1823260-2011-02101
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    April 9, 2011
    Report Date
    May 3, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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 NEONATE RECEIVED THE RESULTS OF 39 MG/DL AND 38 MG/DL ON THE INFORM SYSTEM COMPARED BACK TO BACK WITHIN 10 MINUTES OF A RESULT OF 23 MG/DL OBTAINED ON A LAB SYSTEM. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT.

    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 551460

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA