BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 2033599 · Received March 30, 2011

    Report

    Report Number
    1823260-2011-01698
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    February 25, 2011
    Report Date
    May 19, 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

    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 478 MG/DL AND 162 MG/DL BACK TO BACK WITHIN 10 MINUTES ON THE AVIVA SYSTEM. REPORTER STATED THAT HE TOOK 500 MG O METFORMIN AND 10 MG OF GLIPIZIDE MINUTES BEFORE GETTING THE READINGS. REPORTER STATED THAT HE ATE BREAKFAST AFTER THE READINGS. 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
    1 056 YR GLIPIZIDE| "OPC-POWEDERED VITAMIN"| METFORMIN