BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 2170593 · Received July 21, 2011

    Report

    Report Number
    1823260-2011-03878
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    July 4, 2011
    Report Date
    August 3, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CUSTOMER'S BOYFRIEND STATES THAT THE CUSTOMER PASSED OUT AND HE CALLED THE EMTS. THE EMT ARRIVED AND TESTED THE CUSTOMER AT 27 MG/DL ON THEIR METER. CUSTOMER WAS TREATED WITH AN IV (CONTENTS UNKNOWN) AND TESTED AT 317 MG/DL ON THE EMT METER ABOUT 5-6 MINUTES AFTER THE INITIAL READING. EMT THEN TESTED THE CUSTOMER ON HER AVIVA METER AT 198 MG/DL, ABOUT 6-7 MINUTES AFTER THE INITIAL READING. CUSTOMER WAS NOT TAKEN TO THE HOSPITAL. CUSTOMER CURRENTLY FEELS FINE. NO ACTIONS TAKEN BASED ON AVIVA DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 302758

    Patients

    Seq Age Sex Outcome Treatment
    1 063 YR ALENDRONATE| LANTUS| SIMVASTATIN| HYDROCHLOROTHIAZIDE| VITAMIN D| LISINOPRIL| HUMALOG| AMLODIPINE BESYLATE| METOPROLOL| PLAVIX