BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1803022 · Received August 17, 2010

    Report

    Report Number
    1823260-2010-04879
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    August 10, 2010
    Report Date
    August 17, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A RESULT OF 114 MG/DL ON THE AVIVA SYSTEM COMPARED BACK TO BACK WITH A RESULT OF 250 MG/DL ON THE ADVANTAGE SYSTEM WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES. REPORTER ALLEGED, AT ANOTHER TIME, OBTAINING A RESULT OF 114 MG/DL ON THE AVIVA SYSTEM COMPARED BACK TO BACK WITH A RESULT OF 299 MG/DL ON THE ADVANTAGE SYSTEM WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES. 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 302355

    Patients

    Seq Age Sex Outcome Treatment
    1 051 YR OMEGA 3 FISH OIL| ASPIRIN| METFORMIN| CINNAMON| CALCIUM| VISTARIL| DIPHENHYDRAMINE| GLIPIZIDE| HEART STENT| BLOOD PRESSURE MONITOR| NEXIUM| BACLOFEN| BENAZEPRIL| LOPID| TRAZADONE| NEURONTIN| CENTRUM CARDIO| WELLBUTRIN