BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 3053424 · Received April 11, 2013

    Report

    Report Number
    1823260-2013-02231
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 20, 2013
    Report Date
    May 30, 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)(4). THIS MEDWATCH IS FOR THE COMPACT PLUS SYSTEM 2. (B)(4).

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(4). THIS MEDWATCH IS FOR THE COMPACT PLUS SYSTEM 2. (B)(4).

    Description of Event or Problem · 1

    REPORTER STATED THAT CUSTOMER RECEIVED THE FOLLOWING RESULTS ON TWO DIFFERENT METERS WITHIN 10 MINUTES: 4.3 MMOL/L AND 13.8 MMOL/L (COMPACT PLUS SYSTEM 1) AND 10.8 MMOL/L AND 11.3 MMOL/L (COMPACT PLUS SYSTEM 2) NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. THE MANUFACTURER REQUESTED RETURN OF SUSPECT PRODUCT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156727 ACCU-CHEK ® COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 070 YR