BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1003473 · Received February 21, 2008

    Report

    Report Number
    1823260-2008-01775
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Date of Event
    February 8, 2008
    Report Date
    February 21, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTS BACK TO BACK TESTING ON THE SAME METER WHILE USING THE INFORM SYSTEM WITH RESULTS OF 90MG/DL AND 161MG/DL. NO QC INFO WAS PROVIDED. PT TREATMENT INFO WAS NOT PROVIDED. A REQUEST WAS MADE FOR RETURN OF THE SUSPECT PRODUCT AND A 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 LFR ROCHE DIAGNOSTICS 549713

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK NOVOLIN R/VIAL 1 UNIT| CALCIUM CARBONATE 50| SENNA SOD TABLET 8.6| COSOPT EYE DROPS| LEVOTHROID 0.175 TAB| INSULIN HUMALOG 100 UNITS| LISINOPRIL 10 MG| MILK OF MAGNESIA SUSP| MAG HYDROXIDE/AL HYD| PAXIL CR 25 MG| HYDROXYZINE PAMOATE 25 MG| TRAVATAN Z| TRAZODONE 100 MG| NORVASC 5 MG| ACETAMINOPHEN 325 MG| AMARYL