BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK INFORM II TEST STRIPS

    MDR report key: 3118305 · Received May 17, 2013

    Report

    Report Number
    1823260-2013-03038
    Event Type
    Malfunction
    Date Received
    May 17, 2013
    Date of Event
    April 19, 2013
    Report Date
    May 17, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 471066, EXPIRATION DATE 03/31/2014). (B)(6).

    Description of Event or Problem · 1

    CALLER STATES THE PATIENT TESTED 1.9 MMOL/L (22:14) ON INFORM II, SYSTEM 1. THE PATIENT RECEIVED AN INTRAMUSCULAR INJECTION OF GLUCAGON HYDROCHLORIDE. APPROXIMATELY 20 MINUTES LATER THE PATIENT TESTED 1.7 MMOL/L (22:31) ON INFORM II, SYSTEM 1. AT 22:37 THE PATIENT TESTED 30.0 MMOL/L ON INFORM II, SYSTEM 2. PATIENT THEN TESTED 2.3 MMOL/L (22:41) ON INFORM II, SYSTEM 1. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE HOWEVER THE TEST STRIPS WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219594 ACCU-CHEK INFORM II TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 471066

    Patients

    Seq Age Sex Outcome Treatment
    1