BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MOBILE TEST STRIPS

    MDR report key: 1903742 · Received November 20, 2010

    Report

    Report Number
    1823260-2010-06881
    Event Type
    Malfunction
    Date Received
    November 20, 2010
    Date of Event
    November 8, 2010
    Report Date
    December 20, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    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 THE MOBILE SYSTEM (LOT NUMBER 277038, EXPIRATION DATE 07/31/2011). (B)(6).

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULT OF 11.0 MMOL/L ON THE MOBILE SYSTEM AND 3.5 MMOL/L ON THE AVIVA SYSTEM WITHIN 10 MINUTES. LOW BLOOD GLUCOSE SYMPTOMS WERE REPORTED WITH THESE RESULTS. CUSTOMER ATE LUNCH AND LOW BLOOD GLUCOSE SYMPTOMS IMPROVED. 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 277038

    Patients

    Seq Age Sex Outcome Treatment
    1 063 YR LANTUS TWICE DAILY| HUMALOG 3 TIMES DAILY