BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1792124 · Received August 10, 2010

    Report

    Report Number
    1823260-2010-04719
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    July 25, 2010
    Report Date
    October 29, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. (B)(4)

    Description of Event or Problem · 1

    ON (B)(6) 2007, THE PATIENT BEGAN PERITONEAL DIALYSIS (PD) TREATMENT. IN 2010, A BREAK IN ASEPTIC TECHNIQUE OCCURRED. ON (B)(6) 2010, THE PATIENT WAS DIAGNOSED AND HOSPITALIZED FOR BACTERIAL PERITONITIS. A PERITONEAL EFFLUENT CULTURE WAS PERFORMED, WHICH REVEALED (B)(6). THE TREATMENT WAS NOT REPORTED. IT WAS NOT REPORTED WHETHER PD THERAPY WAS ONGOING. ON (B)(6) 2010, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON AN UNREPORTED DATE IN (B)(6) 2010, THE BACTERIAL PERITONITIS RESOLVED. CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE REPORTING NURSE STATED THAT THE PERITONITIS WAS UNRELATED TO THE PD THERAPY. THE REPORTING NURSE DID NOT PROVIDE A CAUSALITY STATEMENT FOR THE EVENT OF BREAK IN ASEPTIC TECHNIQUE.

    Description of Event or Problem · 1

    CALLER REPORTED BLOOD GLUCOSE RESULTS OF 468 MG/DL AND 444 MG/DL MG/DL ON ADVANTAGE SYSTEM 1, 138 MG/DL AND 149 ON ADVANTAGE SYSTEM 2 WITHIN 10 MINUTES. REPORTED NO ADVERSE EVENT RELATIVE TO DISCREPANCY. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT 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 551248

    Patients

    Seq Age Sex Outcome Treatment
    1 058 YR BLOOD PRESSURE MONITOR| LONG ACTING INSULIN| SHORT ACTING INSULIN