BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1181344 · Received September 23, 2008

    Report

    Report Number
    1823260-2008-07091
    Event Type
    Malfunction
    Date Received
    September 23, 2008
    Date of Event
    September 14, 2008
    Report Date
    September 23, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 2 (LOT NUMBER 550678, EXPIRATION DATE 09/30/2009). REFERENCE MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 1.

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING DISCREPANT BLOOD GLUCOSE RESULTS OF 241 MG/DL AND 125 MG/DL ON A PATIENT USING INFORM SYSTEM 1 COMPARED BACK TO BACK WITH A RESULT OF 121 MG/DL ON THE INFORM SYSTEM 2 WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF 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 550678

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR CLOPIDOGREL BISULFATE - 75 MG DAILY| TAMSULOSIN HCL - 0.4 MG NIGHTLY| "MAGN HYD" - 30 ML AS NEEDED| PROMETHAZINE HCL - 37.5 MG AS NEEDED| FLEET ENEMA - AS NEEDED TWICE WEEKLY| "MAG ALUM HYDROX SIME" - 30 ML AS NEEDED| ACETAMINOPHEN - 650 MG AS NEEDED| VALSARTAN - 160 MG NIGHTLY| SIMVASTATIN - 40 MG DAILY| POLYETHYLENE GLYCOL| METFORMIN HCL - 500 MG TWICE DAILY| ASPIRIN EC - 325 MG DAILY| DIPHENHYDRAMINE HCL - 12.5 MG NIGHTLY| "EPC CREAM" - APPLIED AS NEEDED DAILY| HUMALOG - SLIDING SCALE| MELOXICAM - 7.5 MG DAILY| LORAZEPAM - 2 MG DAILY| LISINOPRIL - 20 MG NIGHTLY