BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1941391 · Received December 29, 2010

    Report

    Report Number
    1823260-2010-07740
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    November 4, 2010
    Report Date
    February 24, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED THAT A PATIENT RECEIVED RESULTS OF HI (GREATER THAN 600 MG/DL) AND 105 MG/DL ON THE INFORM SYSTEM COMPARED BACK TO BACK WITHIN 10 MINUTES OF A RESULT OF 2000 MG/DL OBTAINED ON A LAB SYSTEM. REPORTER STATES THEY DREW THE BLOOD SAMPLE FOR THE FIRST TEST AND THE LAB TEST FROM A PICC LINE AND ADMITS THAT THEY DID NOT FLUSH IT AND D-50 WAS PRESENT IN THE LINE. REPORTER STATED THAT THE PATIENT DID NOT RECEIVE TREATMENT BASED ON THE RESULTS. NO OTHER 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 551365

    Patients

    Seq Age Sex Outcome Treatment
    1