BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 3233970 · Received July 18, 2013

    Report

    Report Number
    1823260-2013-04345
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 19, 2013
    Report Date
    August 26, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CALLER STATES THAT A PATIENT RECEIVED THE FOLLOWING READINGS ON AN INFORM SYSTEM, COMPARED TO A LAB RESULT, WITHIN 10 MINUTES: 499 MG/DL, HI (GREATER THAN 600 MG/DL) (INFORM) AND 63 MG/DL (LAB). PATIENT ARRIVED AT THE ER WITH SYMPTOMS OF SHAKINESS, SWEATINESS, AND CONFUSION. PATIENT WAS TREATED WITH ORANGE JUICE AND GLUCOSE IN THE AMBULANCE RIDE TO THE ER. AN INTRAVENOUS OF UNKNOWN CONTENTS WAS STARTED. PATIENT WAS NOT TREATED BASED UPON METER RESULTS. CALLER STATES THAT CONTROLS WERE RUN AND PASSED PRIOR TO THE INCIDENT. 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
    334987 ACCU-CHEK ® COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 551872

    Patients

    Seq Age Sex Outcome Treatment
    1 092 YR ASPIRIN 1X DAILY| CHLORTHALIDONE 1X DAILY| VICODIN 1X DAILY| AMLODIPINE 1X DAILY| AMARYL 1X DAILY| LISINOPRIL 1X DAILY| ATENOLOL 1X DAILY