BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST STRIPS

    MDR report key: 2586130 · Received May 24, 2012

    Report

    Report Number
    1823260-2012-02757
    Event Type
    Malfunction
    Date Received
    May 24, 2012
    Date of Event
    May 1, 2012
    Report Date
    May 24, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). STRIPS NOT AVAILABLE FOR RETURN.

    Description of Event or Problem · 1

    CALLER REPORTED COMPACT PLUS BLOOD GLUCOSE RESULTS OF LO, WHICH ON THE SYSTEM INDICATES A RESULT OF LESS THAN 0.6 MMOL/L, LO, AND 5.8 MMOL/L WITHIN 10 MINUTES. NO ADVERSE EVENT WAS REPORTED RELATIVE TO DISCREPANCY. STRIPS NOT AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® COMPACT TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS 00700006595 208042

    Patients

    Seq Age Sex Outcome Treatment
    1 062 YR GLIMEPIRIDE 1XDAY| JANUVIA 1XDAY