BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 2220318 · Received August 23, 2011

    Report

    Report Number
    1823260-2011-04458
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    July 26, 2011
    Report Date
    August 31, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON A ROCHE METER, COMPARED TO A PROFESSIONAL METER, WITHIN 10 MINUTES: 160 MG/DL (AVIVA) AND 34 MG/DL (EMT'S METER) CALLER STATES THAT THE CUSTOMER BECAME UNRESPONSIVE AT DINNERTIME WITH HYPOGLYCEMIC SYMPTOMS OF GLAZED EYES AND SHAKINESS. CALLER TESTED THE CUSTOMER AT 160 MG/DL ON THE AVIVA METER AT THAT TIME. CALLER CALLED THE EMT, WHO TESTED THE CUSTOMER AT 34 MG/DL ABOUT 5-10 MINUTES LATER. CUSTOMER WAS TREATED IMMEDIATELY WITH A "BLAST OF GLUCOSE" BY THE EMT. CUSTOMER BECAME RESPONSIVE WITHIN 5 MINUTES. CUSTOMER WAS THEN TREATED WITH AN IV OF GLUCOSE BY THE EMT. CUSTOMER FELT BETTER WITHIN 10 MORE MINUTES AND TESTED AT 125 MG/DL ON THE EMT METER. NO ACTIONS TAKEN BASED ON 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 303020

    Patients

    Seq Age Sex Outcome Treatment
    1 071 YR HUMULIN N| ACTOS| COZAAR 1X DAILY| BABY ASPIRIN 1X DAILY| LIPITOR 1X DAILY| MULTIVITAMIN 1X DAILY