BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1843859 · Received September 24, 2010

    Report

    Report Number
    1823260-2010-05680
    Event Type
    Malfunction
    Date Received
    September 24, 2010
    Date of Event
    September 20, 2010
    Report Date
    October 5, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 2. (B)(4).

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A RESULT OF 329 MG/DL ON ADVANTAGE SYSTEM 1 COMPARED BACK TO BACK WITH A RESULT OF 124 MG/DL ON ADVANTAGE SYSTEM 2 WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES. REPORTER STATED THAT HE TOOK HIS NORMAL MEDICATIONS AFTER TESTING. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT.

    Description of Event or Problem · 1

    CALLER STATES NEONATE PATIENT RECEIVED THE FOLLOWING PERFORMA SYSTEM/LAB RESULTS WITHIN 10 MINUTES: 91 MG/DL/65 MG/DL. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND 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 551339

    Patients

    Seq Age Sex Outcome Treatment
    1 076 YR BLOOD PRESSURE MONITOR| ZESTORETIC LUPINPHAR| ACTOS| METFORMIN| GLUCOTROL XL