BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MOBILE TEST STRIPS

    MDR report key: 2832273 · Received November 14, 2012

    Report

    Report Number
    1823260-2012-05756
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 18, 2012
    Report Date
    January 28, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    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 IS FOR THE SUSPECT PRODUCT USED WITH THE ACCU-CHEK MOBILE SYSTEM. (B)(6).

    Description of Event or Problem · 1

    REPORTER STATED THAT PATIENT'S BLOOD GLUCOSE WAS TESTED ON THE ACCU-CHEK MOBILE SYSTEM WHICH REPORTED A RESULT OF 7.8 MMOL/L. PATIENT'S BLOOD GLUCOSE WAS RETESTED, 1 MINUTE LATER, ON AN ACCU-CHEK COMPACT PLUS SYSTEM WHICH PRODUCED A RESULT OF 3.8 MMOL/L. PATIENT'S THERAPY WAS NOT MODIFIED BASED ON THE RESULT OBTAINED ON THE MOBILE SYSTEM. NO ADVERSE EVENT WAS REPORTED. THE MANUFACTURER REQUESTED THE RETURN OF THE SUSPECT PRODUCT FOR EVALUATION.

    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 278183

    Patients

    Seq Age Sex Outcome Treatment
    1 080 YR MAREVAN| NOVORAPID| LANTUS