BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1823779 · Received September 2, 2010

    Report

    Report Number
    1823260-2010-05217
    Event Type
    Malfunction
    Date Received
    September 2, 2010
    Date of Event
    August 25, 2010
    Report Date
    October 26, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE FACILITY REPORTED A COLLEAGUE INFUSION PUMP WITH FAILURE CODE 808:02, WHICH OCCURRED ON CHANNEL A. ACCORDING TO THE FACILITY, THIS EVENT OCCURRED IN THE CRITICAL CARE UNIT. UPON REVIEWING THE PUMP'S EVENT HISTORY, BAXTER QUALITY ENGINEERING DISCOVERED THIS EVENT INTERRUPTED DELIVERY. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS DEVICE IS A REMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 6.13.90.

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING THE FOLLOWING READINGS ON THE ADVANTAGE SYSTEM WITHIN 10 MINUTES: 308 MG/DL AND 128 MG/DL; 406 MG/DL AND 172 MG/DL; HI (GREATER THAN 600 MG/DL) AND 205 MG/DL. THE REPORTER STATED THAT HE TOOK HIS INSULIN, EACH TIME, BASED UPON THE LOWER RESULT. 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 DEVICE LFR ROCHE DIAGNOSTICS 551259

    Patients

    Seq Age Sex Outcome Treatment
    1 069 YR LORITINE| "ASPIR"| PLAVIX| "AMLODIPINE DESYTELE"| METOPROLOL TARTRATE| HYDROCHLOROTHIAZIDE (DAILY)| LANTUS| LOSARTAN| GLIMEPIRIDE| ONGLYZA