BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1810308 · Received August 20, 2010

    Report

    Report Number
    1823260-2010-04997
    Event Type
    Malfunction
    Date Received
    August 20, 2010
    Date of Event
    August 9, 2010
    Report Date
    August 20, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 1. (B)(4).

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING THE RESULTS OF 426 MG/DL (8:32 PM) AND 281 MG/DL (8:38 PM) ON AVIVA SYSTEM 1 COMPARED BACK TO BACK WITH A RESULT OF 97 MG/DL (8:41 PM) ON AVIVA SYSTEM 2 WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES. REPORTER STATED THAT PRIOR TO OBTAINING THE READINGS, HE DID NOT FEEL GOOD, THOUGHT HE WAS HYPOGLYCEMIC AND ATE SOME ICE CREAM WHEN HE TESTED 50 MG/DL AT 6:59 PM. 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 302068

    Patients

    Seq Age Sex Outcome Treatment
    1 059 YR ASPIRIN| APIDRA| LANTUS| VITAMINS| "75/25 HUMALOG"