BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 2250148 · Received September 15, 2011

    Report

    Report Number
    1823260-2011-04894
    Event Type
    Malfunction
    Date Received
    September 15, 2011
    Date of Event
    August 19, 2011
    Report Date
    September 15, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CALLER STATES THAT A PATIENT PRESENTED UNRESPONSIVE TO THE ER. FAMILY STATED THAT THE PATIENT'S READINGS WERE "IN THE 30S" AT HOME. ABOUT 5 MINUTES AFTER ARRIVING AT THE ER, CALLER STATES THAT THE PATIENT REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON AN INFORM METER, COMPARED TO LAB RESULTS, WITHIN 10 MINUTES: 199 MG/DL (INFORM METER) AND 41 MG/DL (LAB). ABOUT 5 MINUTES LATER, CALLER ALLEGED THAT THE PATIENT REPORTEDLY RECEIVED THE FOLLOWING RESULTS, WITH TWO DIFFERENT ROCHE METERS, WITHIN 10 MINUTES: 199 MG/DL (INFORM SYSTEM 1) AND 530 MG/DL (INFORM SYSTEM 2). ONE MINUTE AFTER THESE DISCREPANT RESULTS, THE PATIENT WAS TREATED WITH 1/2 AMPOULE OF D-50 BASED UPON HER SYMPTOMS. FLOOR STAFF THEN CONDUCTED CONTROL TESTING ON BOTH METERS, AND BOTH METERS PASSED. THREE MINUTES LATER, INFORM SYSTEM 2 WAS TESTED WITH A VENOUS SAMPLE FROM THE CUSTOMER, AT 50 MG/DL, WHICH WAS WITHIN 10 MINUTES OF THE READINGS OF 199 MG/DL AND 530 MG/DL. PATIENT WAS REVIVED BY THIS TIME. NO ADVERSE EVENT OR DELAY OF TREATMENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND 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 551475

    Patients

    Seq Age Sex Outcome Treatment
    1 019 YR NOVOLOG PUMP