BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 2032377 · Received March 29, 2011

    Report

    Report Number
    1823260-2011-01664
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    March 15, 2011
    Report Date
    April 11, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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

    REPORTER ALLEGED OBTAINING THE RESULTS OF 64 MG/DL AND 142 MG/DL BACK TO BACK WITHIN 10 MINUTES ON THE AVIVA SYSTEM. REPORTER STATED THAT SHE TOOK 3 GLUCOSE TABLETS BECAUSE SHE WAS SHAKY AND SWEATY IN BETWEEN THE TWO RESULTS. 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 303182

    Patients

    Seq Age Sex Outcome Treatment
    1 060 YR LEVOTHROID| LANTUS (DAILY)| EZETIMIBE (DAILY)| METFORMIN (3 TIMES DAILY)| SULFACETAMIDE (DAILY)| ACETAMINOPHEN (AS NEEDED)| ASPIRIN (DAILY)| MAGNESIUM (DAILY)| FUROSEMIDE (DAILY)| SIMVASTATIN (DAILY)| CLONAZEPAM (DAILY)| PROPOXYPHENE (DAILY)| ISOSORBIDE (DAILY)| STENT| HUMALOG U500 (3 TIMES DAILY)| CITALOPRAM (DAILY)