BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1981784 · Received February 8, 2011

    Report

    Report Number
    1823260-2011-00696
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 26, 2011
    Report Date
    April 4, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WILL NOT BE RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    CUSTOMER STATES THAT A PATIENT REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE INFORM SYSTEM WITHIN 10 MINUTES: 331 MG/DL AND 112 MG/DL. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE; HOWEVER, CUSTOMER NO LONGER HAS STRIPS. 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 551462

    Patients

    Seq Age Sex Outcome Treatment
    1 085 YR IV PIC LINE| SYNTHROID| REGLAN| LASIX| PEPCID| MULTIPLE VITAMINS| POTASSIUM| FEEDING TUBE| INSULIN PH| HYDROCORTOZONE| LISINOPRIL