BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1346284 · Received February 4, 2009

    Report

    Report Number
    1823260-2009-00861
    Event Type
    Malfunction
    Date Received
    February 4, 2009
    Date of Event
    January 5, 2009
    Report Date
    February 4, 2009
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN A FOREIGN COUNTRY.

    Description of Event or Problem · 1

    REPORTER STATED THAT PT OBTAINED THE FOLLOWING BACK-TO-BACK RESULTS ON THE COMPACT PLUS SYSTEM: 17.4 MMOL/L AND 3.9 MMOL/L, 18.3 MMOL/L AND 3.4 MMOL/L, 4.8 MMOL/L AND 1.0 MMOL/L, 5.2 MMOL/L AND 0.5 MMOL/L, 4.8 MMOL/L AND 1.1 MMOL/L, 4.8 MMOL/L AND 1.8 MMOL/L, 4.6 MMOL/L AND 1.0 MMOL/L, 3.8 MMOL/L AND 0.6 MMOL/L, 5.9 MMOL/L AND 1.0 MMOL/L, 4.2 MMOL/L AND 0.9 MMOL/L. NO ADVERSE EVENT ASSOCIATED WITH THE ALLEGED MALFUNCTION WAS REPORTED. THE SUSPECT PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK