BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 2231765 · Received September 1, 2011

    Report

    Report Number
    1823260-2011-04701
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 13, 2011
    Report Date
    September 8, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE AVIVA SYSTEM WITHIN 10 MINUTES: 549 MG/DL, 206 MG/DL, AND 134 MG/DL. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT 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
    1 065 YR VITAMIN C| HUMALOG| MAGNESIUM| VITAMIN E| LEVEMIR| CHOLEST OFF| RED YEAST RICE| CALCIUM AND VITAMIN D| CINNAMON| MANGANESE| NOVOLIN| FLAXSEED OIL| CRANBERRY| FUROSEMIDE| LISINOPRIL| SEA KELP| TURMERIC| GINKGO BILOBA| FISH OIL| ZINC| GYMNEMA SYLVESTRE| NIACIN| BIOTIN| OCUVITE| HAWTHORNE BERRIES| GRAPE SEED RESVERATROL| LIPITOR| OMEGA 3 SALMON OIL| LEVOTHYROXINE| BILBERRY| CENTRUM SILVER| LUTEIN| SHARK CARTILAGE| B12| BABY ASPRIN| SELENIUM