BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 2911622 · Received March 2, 2007

    Report

    Report Number
    1823260-2007-01821
    Event Type
    Malfunction
    Date Received
    March 2, 2007
    Date of Event
    January 26, 2007
    Report Date
    March 2, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT PRODUCT IS THE COMFORT CURVE TEST STRIPS.

    Description of Event or Problem · 1

    REPORTER USING ACCU-CHEK INFORM SYSTEM. REPORTER STATES METER RESULTS READ "HI" COMPARED IN 3 MINUTES TO A LAB RESULT OF 100MG/DL. PATIENT WAS TREATED WITH 10 UNITS OF INSULIN BASED ON METER RESULTS AND THEN GOT LOW BLOOD GLUCOSE SYMPTOMS. REPORTER STATES PATIENT TREATED WITH GLUCOSE. LOCATION OF TREATMENT WAS HOSPITAL EMERGENCY DEPARTMENT. REPORTER STATES NO DEATH OR SERIOUS INJURY OCCURRED. QUALITY CONTROLS WERE RAN AND EVENTUALLY PASSED. A REQUEST WAS MADE FOR RETURN OF THE SUSPECT PRODUCT AND A REPLACEMENT WAS SENT. ACCU-CHECK INFORM SYSTEM: METER # (B)(4), ACCU-CHEK COMFORT CURVE TEST STRIPS LOT # 549543, EXP DATE # 03/31/2008.

    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 549543

    Patients

    Seq Age Sex Outcome Treatment
    1 NA GLUCOSE - USED IN ED FOR TREATMENT NP| R INSULIN - USED IN ED FOR TREATMENT 10 UNI