BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 3092458 · Received May 3, 2013

    Report

    Report Number
    1823260-2013-02742
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 8, 2013
    Report Date
    June 13, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. REFERENCE THE FOLLOWING MEDWATCHES WITH PATIENT IDENTIFIERS FOR THE FOLLOWING SYSTEMS: (B)(6) - INFORM SYSTEM 1 (B)(6) - INFORM SYSTEM 2.

    Description of Event or Problem · 1

    CALLER STATES THAT THE FOLLOWING READINGS WERE OBTAINED ON A PATIENT, USING TWO INFORM METERS, WITHIN 14 MINUTES: 347 MG/DL (INFORM SYSTEM 1), 93 MG/DL (INFORM SYSTEM 2), AND 45 MG/DL (INFORM SYSTEM 1). CALLER IS UNSURE IF THE STRIPS WERE FROM THE SAME VIAL, OR MULTIPLE VIALS; HOWEVER, THE STRIP LOT WAS THE SAME. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND STRIPS, AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194048 ACCU-CHEK ® COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 551841

    Patients

    Seq Age Sex Outcome Treatment
    1 078 YR CYMBALTA 1X DAILY| LOVENOX 1X DAILY| AMLODIPINE 1X DAILY| PRAVASTATIN 1X DAILY| NPH 1X NIGHTLY| ASPIRIN 1X DAILY| IRON 1X DAILY| NADOLOL 1X DAILY| OXYBUTYNIN PATCH 1X DAILY