BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1823776 · Received September 2, 2010

    Report

    Report Number
    1823260-2010-05212
    Event Type
    Malfunction
    Date Received
    September 2, 2010
    Date of Event
    August 25, 2010
    Report Date
    September 30, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). CALLER DID NOT PROVIDE PRODUCT INFORMATION FOR THE SENSOR SYSTEM.

    Description of Event or Problem · 1

    CALLER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON AN ADVANTAGE METER, COMPARED TO A PROFESSIONAL METER, WITHIN 10 MINUTES: 184 MG/DL (ADVANTAGE) AND 96 MG/DL (AT-HOME NURSE'S METER) NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE; HOWEVER, THE STRIPS WERE DISCARDED. REPLACEMENT WAS SENT.

    Description of Event or Problem · 1

    CALLER STATES NEONATE PATIENT RECEIVED RESULTS OF 51 MG/DL ON THE AVIVA SYSTEM AND 70 MG/DL ON THE SENSOR SYSTEM WITHIN 10 MINUTES. 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 202699

    Patients

    Seq Age Sex Outcome Treatment
    1 012 DA