BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1845008 · Received September 27, 2010

    Report

    Report Number
    1823260-2010-05702
    Event Type
    Injury
    Date Received
    September 27, 2010
    Date of Event
    May 16, 2010
    Report Date
    September 27, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). WILL NOT BE RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    CALLER STATES PATIENT TESTED HI (GREATER THEN 33.3 MMOL/L) ON THE AVIVA SYSTEM. THE PATIENT WAS NAUSEOUS AND VOMITING WITH THIS RESULT. THE NURSE ON DUTY INTERPRETED HI AS "H1" AND REPORTED THE "1" TO THE PHYSICIAN. BASED ON THIS INFORMATION, THE PHYSICIAN ADVISED NURSE TO TREAT THE PATIENT WITH GLUCAGON. A SECOND RESULT OF HI WAS OBTAINED, AND A PHYSICIAN ADVISED THE NURSE TO TREAT THE CUSTOMER WITH UNSPECIFIED INSULIN. PATIENT HAS SINCE BEEN ADMITTED TO AN INTENSIVE CARE UNIT; HER CURRENT CONDITION IS NOT KNOWN. REQUESTED RETURN OF SUSPECT DEVICE HOWEVER CALLER NO LONGER HAS THE TEST STRIPS.

    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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention