BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 2220873 · Received August 23, 2011

    Report

    Report Number
    1823260-2011-04523
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    August 3, 2011
    Report Date
    September 28, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING THE RESULTS OF HI (GREATER THAN 600 MG/DL) AND 351 ON THE AVIVA SYSTEM COMPARED BACK TO BACK WITH A RESULT OF 125 MG/DL ON A PROFESSIONAL SYSTEM WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES. REPORTER STATED THAT HE TOOK HIS REGULAR BASELINE DOES OF 80 UNITS OF LANTUS AND 12 UNITS OF REGULAR NOVOLOG, THEN ATE HIS BREAKFAST. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT.

    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 303197

    Patients

    Seq Age Sex Outcome Treatment
    1 045 YR BACLOFEN| NASONEX| NOVOLOG| RESCUE INHALER AS NEEDED| LANTUS| NEURONTIN