BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 2071920 · Received April 28, 2011

    Report

    Report Number
    1823260-2011-02300
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    April 12, 2011
    Report Date
    May 2, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CALLER REPORTED HAVING SYMPTOMS OF HYPOGLYCEMIA, TOOK AVIVA BLOOD GLUCOSE RESULTS OF 210 MG/DL, 129 MG/DL, 78 MG/DL, 164 MG/DL, 70 MG/DL, AND 82 MG/DL, WITHIN 10 MINUTES. CUSTOMER RETREIVED AND SELF-TREATED WITH JUICE. CUSTOMER FELT BETTER, RETEST RESULTS 22 MINUTES LATER WERE 98 MG/DL AND 103 MG/DL WITHIN 1 MINUTE. REPORTED NO ADVERSE EVENT. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT 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 303199

    Patients

    Seq Age Sex Outcome Treatment
    1 075 YR HUMULIN 70/30