BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 2801352 · Received October 23, 2012

    Report

    Report Number
    1823260-2012-05318
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Date of Event
    September 11, 2012
    Report Date
    November 15, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE ADVANTAGE SYSTEM WITHIN 10 MINUTES: 325 MG/DL AND 66 MG/DL. CUSTOMER WAS FEELING HYPOGLYCEMIC SYMPTOMS OF SWEATING AND SHAKING AT THE TIME OF THE READINGS. CUSTOMER SELF-TREATED WITH ORANGE JUICE AND FELT BETTER WITHIN 10-15 MINUTES. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND STRIPS, AND REPLACEMENT WAS SENT. CUSTOMER STATES SHE OBTAINED A READING OF 101 MG/DL ON THE ADVANTAGE SYSTEM, BUT FELT HYPOGLYCEMIC SYMPTOMS OF SHAKING AND SWEATING. CUSTOMER SELF-TREATED WITH ORANGE JUICE AND FELT BETTER IN 15 MINUTES. 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
    1 ACCU-CHEK ® COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 551622

    Patients

    Seq Age Sex Outcome Treatment
    1 068 YR COLACE| BUSPAR| REGLAN| LORTAB| VITAMIN D| EVISTA| NEURONTIN| DURAGESIC| ATENOLOL| LISINOPRIL| PREVACID| APIDRA| LANTUS| BRIMONIDINE| DOXEPIN| PANCREAZE