BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1823754 · Received September 2, 2010

    Report

    Report Number
    1823260-2010-05211
    Event Type
    Malfunction
    Date Received
    September 2, 2010
    Date of Event
    August 16, 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). THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 2 (LOT NUMBER 202699, EXPIRATION DATE 10/31/2011). (B)(4).

    Description of Event or Problem · 1

    THE ACCOUNT STATED THAT THE ARCHITECT C16000 ANALYZER GENERATED A CALCIUM RESULT OF <2 MG/DL. THE RESULT WAS FLAGGED AND WAS NOT REPORTED OUT OF THE LAB. THE SAMPLE WAS REPEATED AND A RESULT OF 9.9 MG/DL WAS GENERATED. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT. NO FURTHER PATIENT INFORMATION WAS AVAILABLE.

    Description of Event or Problem · 1

    CALLER STATES NEONATE PATIENT RECEIVED RESULTS OF 36 MG/DL ON AVIVA SYSTEM 1 AND 37 MG/DL ON AVIVA SYSTEM 2 WHILE A COMPARISON LAB RETURNED AS 60 MG/DL. THE REPORTED VALUES WERE OBTAINED WITHIN 10 MINUTES OF EACH OTHER. 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
    1 002 DA