BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MOBILE TEST STRIPS

    MDR report key: 2052935 · Received April 13, 2011

    Report

    Report Number
    1823260-2011-02020
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    March 23, 2011
    Report Date
    May 19, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    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). THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 2 (LOT NUMBER 277064, EXPIRATION DATE 11/30/2011). REFERENCE MEDWATCH REPORT WITH PATIENT IDENTIFIER (B)(6) FOR THE SUSPECT DEVICE USED IN SYSTEM 1.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULTS OF 14.3 MMOL/L ON MOBILE SYSTEM 1 AND 2.3 MMOL/L ON MOBILE SYSTEM 2 WITHIN 10 MINUTES. LOW BLOOD GLUCOSE SYMPTOMS WERE REPORTED WITH THESE RESULTS. NO ADVERSE EVENT RELATED TO THE DEVICE WAS REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® MOBILE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 277064

    Patients

    Seq Age Sex Outcome Treatment
    1 042 YR UNKNOWN "PUMP"