BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MOBILE TEST STRIPS

    MDR report key: 3420427 · Received October 21, 2013

    Report

    Report Number
    1823260-2013-06434
    Event Type
    Malfunction
    Date Received
    October 21, 2013
    Date of Event
    September 10, 2013
    Report Date
    October 23, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. DEVICE RECEIVED IN A CONDITION WHICH MADE ANALYSIS IMPOSSIBLE. UNABLE TO TEST BECAUSE AN EMPTY VIAL WAS RETURNED.

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(4). WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES. CUSTOMER INDICATED THAT THE CASSETTE WAS DISPOSED OF AND UNAVAILABLE FOR RETURN. DEVICE WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE MOBILE SYSTEM WITHIN 10 MINUTES: 5.7 MMOL/L, 12.1 MMOL/L, HI (GREATER THAN 33.3 MMOL/L), AND 15.5 MMOL/L. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE, HOWEVER THE CUSTOMER RETURNED AM EMPTY TEST CASSETTE.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE MOBILE SYSTEM WITHIN 10 MINUTES: 5.7 MMOL/L, 12.1 MMOL/L, HI (GREATER THAN 33.3 MMOL/L), AND 15.5 MMOL/L. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE, HOWEVER, THE CASSETTE HAS BEEN DISPOSED OF AND NOT AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538347 ACCU-CHEK ® MOBILE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 278251

    Patients

    Seq Age Sex Outcome Treatment
    1 071 YR