BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 2884634 · Received December 24, 2012

    Report

    Report Number
    1823260-2012-06508
    Event Type
    Malfunction
    Date Received
    December 24, 2012
    Date of Event
    October 1, 2012
    Report Date
    January 17, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    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. ABSENT THE DEVICE LOT NUMBER, MANUFACTURE DATE CANNOT BE DETERMINED. STRIPS NOT AVAILABLE FOR RETURN.

    Description of Event or Problem · 1

    CALLER REPORTED AVIVA SYSTEM BLOOD GLUCOSE RESULTS OF 450 MG/DL, 380 MG/DL, 160 MG/DL, AND 190 MG/DL WITHIN 10 MINUTES. NO ADVERSE EVENT WAS REPORTED. STRIPS ARE NOT AVAILABLE FOR RETURN, 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 064 YR CALCIUM CALTRATE + D| POTASSIUM| METOPROLOL TARTRATE| LEVEMIR| FUROSEMIDE| SIMVASTATIN| BOFLEX| OMEGA 3| ARTIFICIAL HEART VALVE| PACEMAKER| NOVOLOG| ASPIRIN| RANITIDINE| MULTI VITAMIN| FISH OIL