BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1890353 · Received November 3, 2010

    Report

    Report Number
    1823260-2010-06558
    Event Type
    Injury
    Date Received
    November 3, 2010
    Date of Event
    October 15, 2010
    Report Date
    December 16, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE ATRIAL LEAD HAD IMPEDANCE OF 109 OHMS BIPOLAR AND CAPTURE THRESHOLD WERE 4 VOLTS WITH NO CAPTURE IN UNIPOLAR POLARITY. INSULATION BREACH WAS SUSPECTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. LATER REVIEW OF MANUFACTURER'S DATABASE REVEALED THE PATIENT HAD EXPIRED. FOLLOW UP REPORTED DEVICE CHECK (B)(6) 2008 SHOWED ATRIAL LEAD WARNING WITH LOW IMPEDANCE IN BIPOLAR. REPROGRAMMING HAD BEEN TRIED, BUT PATIENT WOULD NOT TOLERATE UNIPOLAR. SCHEDULED TO FOLLOW UP IN ONE MONTH. IN (B)(6) 2009, CARDIOLOGIST QUESTIONING PACEMAKER MALFUNCTION AND TOLD "TOP LEAD NOT WORKING." THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    CALLER REPORTS THAT THE CUSTOMER HAD A HYPOGLYCEMIC EVENT. CALLER TESTED THE CUSTOMER AT THE TIME AND OBTAINED A READING OF 91 MG/DL. THE CUSTOMER WAS EXPERIENCING HYPOGLYCEMIC SYMPTOMS AT THE TIME OF THE READING OF BEING DISORIENTED AND DID NOT KNOW WHAT WAS HAPPENING. THE CALLER TOOK THE CUSTOMER TO THE HOSPITAL, WHERE HE TESTED AT 25 MG/DL ABOUT 30 MINUTES AFTER THE READING OF 91 MG/DL. THE CUSTOMER WAS TREATED WITH "SUGAR WATER" (UNKNOWN TRANSMISSION). CUSTOMER IS FEELING FINE. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING DEVICE LFR ROCHE DIAGNOSTICS 551114

    Patients

    Seq Age Sex Outcome Treatment
    1 061 YR Hospitalization TERAZOSIN| SIMVASTATIN| GLARGINE| METFORMIN| HYDROCHLOROTHIAZIDE| OXYGEN