BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 2800365 · Received October 22, 2012

    Report

    Report Number
    1823260-2012-05294
    Event Type
    Malfunction
    Date Received
    October 22, 2012
    Date of Event
    September 21, 2012
    Report Date
    January 31, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K101299
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS MEDWATCH IS FOR THE AVIVA SYSTEM 2. (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS MEDWATCH IS FOR THE AVIVA SYSTEM 2. (B)(4). THE STRIPS THAT WERE RECEIVED WERE AVIVA AND NOT AVIVA PLUS STRIPS AND THEREFORE CANNOT BE ASSOCIATED WITH THIS COMPLAINT. THE LOT NUMBER WAS CHANGED BACK TO ASKU.

    Description of Event or Problem · 1

    CUSTOMER ALLEGEDLY RECEIVED THE FOLLOWING RESULTS, WITH TWO DIFFERENT METERS, WITHIN 10 MINUTES: 124 MG/DL (AVIVA SYSTEM 1) AND 65 MG/DL (AVIVA SYSTEM 2). 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 ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 303449

    Patients

    Seq Age Sex Outcome Treatment
    1 055 YR LASIX| LOSARTAN /HCT| LYRICA| ACTOS| SINGULAIR| LEVEMIR| NOVOLOG| INDOCIN| NEXIUM| FLEXERIL| KLONOPIN| ELAVIL| ASPIRIN| TRILIPIX| CRESTOR| ATENOLOL| HYDRODIURIL| LORTAB| CLARITIN