BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 2141660 · Received June 27, 2011

    Report

    Report Number
    1823260-2011-03479
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    June 21, 2011
    Report Date
    August 1, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 REPORTEDLY RECEIVED RESULTS OF 141 MG/DL AND 51 MG/DL WITHIN 10 MINUTES ON THE AVIVA SYSTEM. LOW BLOOD GLUCOSE SYMPTOMS WERE REPORTED WITH THESE RESULTS. CALLER TREATED THE CUSTOMER WITH GLUCOSE TABLETS, A BANANA, AND A CAN OF SODA. 10 MINUTES AFTER TESTING 51 MG/DL CUSTOMER TESTED 62 MG/DL. LOW BLOOD GLUCOSE SYMPTOMS IMPROVED IN 30 MINUTES. NO ADVERSE EVENT RELATED TO THE DEVICE WAS 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 303181

    Patients

    Seq Age Sex Outcome Treatment
    1 091 YR NOVOLOG 70/30| HEARING AID| WALKER| CANE