BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1002104 · Received February 20, 2008

    Report

    Report Number
    1823260-2008-01725
    Event Type
    Malfunction
    Date Received
    February 20, 2008
    Date of Event
    February 12, 2008
    Report Date
    February 20, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 1 (LOT NUMBER 550508, EXPIRATION DATE 04/30/2009).

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A DISCREPANT BLOOD GLUCOSE RESULT OF 361 MG/DL ON INFORM SYSTEM 1 COMPARED BACK TO BACK WITH A RESULT OF 173 MG/DL ON THE INFORM SYSTEM 2 WHEN TESTING WAS PERFORMED LESS THAN 10 MINS APART ON A PT. REPORTER DID NOT INDICATE THAT PT WAS EXPERIENCING ANY HYPOGLYCEMIC OR HYPERGLYCEMIC SYMPTOMS DURING THE TIME OF TESTING. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE 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 550508

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK TOPROL TIME UNK 25 MG| LISINOPRIL TIME UNK 20 MG| LASIX TIME UNK 40 MG TWICE DAILY| ASPIRIN TIME UNK 325 MG| GLYBURIDE TIME UNK 5 MG| ZOCOR TIME UNK 20 MG| VITAMIN D TIME UNK 400 UNITS