BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK INFORM TEST STRIPS

    MDR report key: 2945539 · Received February 6, 2013

    Report

    Report Number
    1823260-2013-00694
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    December 31, 2012
    Report Date
    March 19, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 1 (LOT NUMBER 551759, EXPIRATION DATE 07/31/2013). (B)(6).

    Description of Event or Problem · 1

    CALLER STATES A KNOWN DIABETIC PATIENT CAME INTO TRIAGE WITH SUSPECTED HYPOGLYCEMIA (THE PATIENT WAS STUMBLING AND PASSING OUT). THE PATIENT TESTED 1.9 MMOL/L ON INFORM SYSTEM 1; A FEW MINUTES LATER THE PATIENT WAS TESTED ON A SECOND INFORM SYSTEM AND ERROR-83 DISPLAYED ON THE METER SCREEN. THE MESSAGE FOLLOWING THIS ERROR READ "EXTREMELY LOW BLOOD GLUCOSE SAMPLE BELOW THE METER'S READING RANGE OR A BAD STRIP. REPEAT TEST OR FOLLOW YOUR FACILITY'S POLICY." THE NURSES WERE UNFAMILIAR WITH THIS ERROR, AND SUSPECTING THE PATIENT WAS SEVERELY HYPOGLYCEMIC TREATED THE PATIENT WITH DEXTROSE 50%. AN HOUR LATER A COMPARISON LAB RETURNED AS 83 MMOL/L. IT IS NOT KNOWN IF THE LAB WAS DRAWN BEFORE OR AFTER TREATMENT WITH DEXTROSE 50%. THE CALLER DID NOT REPORT IF CORRECTION TREATMENT WAS ADMINISTERED TO THE PATIENT FOLLOWING THE LAB VALUE. THE PATIENT'S CURRENT CONDITION IS NOT KNOWN. REQUESTED RETURN OF SUSPECT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49601 ACCU-CHEK INFORM TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 551759

    Patients

    Seq Age Sex Outcome Treatment
    1 019 YR Required Intervention