BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1771233 · Received February 15, 2008

    Report

    Report Number
    1823260-2008-01596
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    January 30, 2008
    Report Date
    February 15, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED THE PATIENT'S BLOOD GLUCOSE READ 106 MG/DL AT 12:24 ON THE INFORM SYSTEM AND AS PART OF THE FACILITY PROTOCOL; THE PATIENT WAS TREATED WITH D-50, AMOUNT AND TYPE NOT PROVIDED. REPORTER STATED A LAB SAMPLE WAS COLLECTED AT 12:30 HOWEVER, THE LAB MEASUREMENT INDICATED PATIENT'S BLOOD GLUCOSE RESULTS WAS 40 MG/DL AT 12:35. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT WAS RECEIVED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT 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 LFR ROCHE DIAGNOSTICS 550012

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR LEVOXYL - TIME UNK, 100UG, FREQUENCY UNK| LEVEMIR - TIME UNK - 50 UNITS ONCE DAILY| LISINOPRIL - TIME UNK - 5MG ONCE DAILY| TYLENOL - TIME UNK, DOSE UNK AS NEEDED| GLUCAGON - TIME UNK, DOSE UNK AS NEEDED| NOVOLOG - TIME UNK - 5-10 UNITS 2-3 TIMES DAILY| LEVEMIR - TIME UNK, 20 UNITS ONCE DAILY| LACHYDRON CREAM - TIME UNK, DOSE UNK AS NEEDED