BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MOBILE TEST STRIPS

    MDR report key: 3093857 · Received May 6, 2013

    Report

    Report Number
    1823260-2013-02754
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    April 4, 2013
    Report Date
    June 21, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    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). WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES. THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN THE MOBILE SYSTEM (LOT NUMBER 278192, EXPIRATION DATE 03/31/2014). DEVICE RECEIVED IN A CONDITION WHICH MADE ANALYSIS IMPOSSIBLE. UNABLE TO TEST BECAUSE AN EMPTY VIAL WAS RETURNED. REFERENCE MEDWATCH REPORT WITH PATIENT IDENTIFIER (B)(6) FOR THE SUSPECT DEVICE USED IN THE COMPACT PLUS SYSTEM.

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES. THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN THE MOBILE SYSTEM (LOT NUMBER 278192, EXPIRATION DATE 03/31/2014). REFERENCE MEDWATCH REPORT WITH PATIENT IDENTIFIER (B)(6) FOR THE SUSPECT DEVICE USED IN THE COMPACT PLUS SYSTEM.

    Description of Event or Problem · 1

    CUSTOMER RECEIVED RESULT OF 6.2 MMOL/L ON THE MOBILE SYSTEM, AND A RESULT OF 3.9 MMOL/L ON THE COMPACT PLUS SYSTEM WITHIN 10 MINUTES. CUSTOMER CONSUMED 3 GLUCOSE TABLETS BASED ON THE RESULT OF 3.9 MMOL/L, WHICH IS HOW SHE FELT DURING THE EVENT. NO ADVERSE EVENT RELATED TO THE DEVICE WAS REPORTED. REQUESTED RETURN OF SUSPECT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196615 ACCU-CHEK ® MOBILE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 278192

    Patients

    Seq Age Sex Outcome Treatment
    1 033 YR CYMBALTA| LIPITOR| SYNTHROID| HUMALOG| DEX4| BUTRANS| "CYCLEN"| LANTUS