BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® PERFORMA TEST STRIPS

    MDR report key: 1963093 · Received January 18, 2011

    Report

    Report Number
    1823260-2011-00276
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    January 5, 2011
    Report Date
    April 21, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    CALLER REPORTED PERFORMA BLOOD GLUCOSE RESULTS OF HI, WHICH ON THE SYSTEM INDICATES A RESULT IN EXCESS OF 33.3 MMOL/L, AND 3.6 MMOL/L, COMPARED WITH A PROFESSIONAL SYSTEM RESULT OF 3.9 MMOL/L WITHIN 10 MINUTES. REPORTED NO ADVERSE EVENT. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® PERFORMA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 370273

    Patients

    Seq Age Sex Outcome Treatment
    1 056 YR CARVEDILOL 2XDAY| SHENKANG INJECTION