BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® PERFORMA TEST STRIPS

    MDR report key: 1802520 · Received August 17, 2010

    Report

    Report Number
    1823260-2010-04874
    Event Type
    Injury
    Date Received
    August 17, 2010
    Date of Event
    July 23, 2010
    Report Date
    November 22, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    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 370216, EXPIRATION DATE 01/31/2011). REFERENCE MEDWATCH REPORT WITH (B)(4) FOR THE SUSPECT DEVICE USED IN SYSTEM 2. CALLER DID NOT HAVE PRODUCT INFORMATION FOR THE ADVANTAGE SYSTEM.

    Description of Event or Problem · 1

    CALLER STATES PATIENT CAME TO THE HOSPITAL WITH LOW BLOOD GLUCOSE SYMPTOMS AND TESTED 3.5 MMOL/L ON LAB VALUE. 30 MINUTES LATER PATIENT TESTED HI (GREATER THEN 33.3 MMOL/L) AND 24.4 MMOL/L ON PERFORMA SYSTEM 1. APPROXIMATELY 1 HOUR LATER A LAB VALUE RETURNED AS 2.0 MMOL/L. ONE HOUR LATER, PATIENT TESTED 0.6 MMOL/L AND LO (LESS THEN 0.6 MMOL/L) ON PERFORMA SYSTEM 1 AND 10 MINUTES LATER, PATIENT TESTED 17.8 MMOL/L AND 16.8 MMOL/L ON PERFORMA SYSTEM 2. PATIENT THEN TESTED 1.6 MMOL/L ON AN ADVANTAGE SYSTEM. PHYSICIAN TREATED THE PATIENT WITH GLUCOSE AND LOW BLOOD GLUCOSE SYMPTOMS IMPROVED. REQUESTED RETURN OF SUSPECT DEVICE.

    Description of Event or Problem · 1

    (B)(6) HEALTHCARE CONTACTED (B)(4) SALES CONSULTANT ON (B)(6)-2010. A STAFF MEMBER WAS EXPOSED TO RAPICIDE PA, IT SPLASHED IN HER EYE WHILE HELPING ANOTHER PERSON CHANGE THE CHEMICAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® PERFORMA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS 370216

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention