BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1982406 · Received February 9, 2011

    Report

    Report Number
    1823260-2011-00711
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Date of Event
    January 24, 2011
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 1. REFERENCE MEDWATCH REPORT WITH PATIENT IDENTIFIER (B)(6) FOR THE SUSPECT DEVICE USED IN SYSTEM 2.

    Description of Event or Problem · 1

    REPORTER ALLEGED THAT A NEONATE RECEIVED THE RESULTS OF 16 MG/DL AND 23 MG/DL ON THE INFORM SYSTEM COMPARED BACK TO BACK WITHIN 10 MINUTES. REPORTER ALLEGED THAT HOURS LATER, THE NEONATE RECEIVED THE RESULT OF 64 MG/DL ON THE LAB SYSTEM AND 33 MG/DL ON THE INFORM SYSTEM COMPARED BACK TO BACK WITHIN 10 MINUTES. REPORTER ALSO ALLEGED THAT THE NEXT DAY, THE NEONATE RECEIVED THE RESULT OF 22 MG/DL ON INFORM SYSTEM 1 COMPARED BACK TO BACK WITHIN 10 MINUTES OF A RESULT OF 72 MG/DL OBTAINED ON INFORM SYSTEM 2. 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 551327

    Patients

    Seq Age Sex Outcome Treatment
    1 014 DA