BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 2507135 · Received March 28, 2012

    Report

    Report Number
    1823260-2012-01636
    Event Type
    Malfunction
    Date Received
    March 28, 2012
    Date of Event
    January 26, 2012
    Report Date
    April 23, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    CALLER STATES THAT THE PATIENT EXPIRED AS OF (B)(6) 2012. CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE AVIVA SYSTEM WITHIN 10 MINUTES ON (B)(6) 2012: 72 MG/DL AND 147 MG/DL. CALLER STATES THAT SOME OF THE CUSTOMER'S STRIPS WERE FOUND OUTSIDE THE VIAL. CALLER DOES NOT KNOW WHETHER THE STRIPS WERE COMPROMISED. NO ADDITIONAL INFORMATION AVAILABLE REGARDING THE DISCREPANT RESULTS. REQUESTED RETURN OF SUSPECT DEVICE AND STRIPS, 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 303430

    Patients

    Seq Age Sex Outcome Treatment
    1