BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1854325 · Received October 5, 2010

    Report

    Report Number
    1823260-2010-05898
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    September 28, 2010
    Report Date
    December 13, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    CALLER REPORTED ADVANTAGE BLOOD GLUCOSE RESULTS OF HI, WHICH ON THE SYSTEM INDICATES A RESULT IN EXCESS OF 600 MG/DL, WITHIN 1 MINUTE 540 MG/DL, WITHIN 1 MINUTE 340 MG/DL, WITHIN 1 MINUTE 200 MG/DL, WITHIN 1 MINUTE 189 MG/DL. REPORTED NO ADVERSE EVENT RELATIVE TO DISCREPANCY. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL LEAD SHOWED HIGH IMPEDANCE, SENSING DIFFICULTY, AND APPARENT FRACTURE. THE RIGHT ATRIAL LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    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 551188

    Patients

    Seq Age Sex Outcome Treatment
    1 076 YR AMLODIPINE 1XDAY| JANUVIA| BYSTOLIC| LEVOTHYROXIN 1XDAY| "BLOOD PRESSURE"| CLONIDINE 1XDAY| OMEPRAZOLE 1XDAY| CHLORDIAZEPOXIDE 1XDAY| BENAZEPRIL 1XDAY| LANTUS| "POCHLORIDE" 2XDAY| TORSEMIDE