BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® PERFORMA TEST STRIPS

    MDR report key: 1852460 · Received October 4, 2010

    Report

    Report Number
    1823260-2010-05876
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    October 1, 2010
    Report Date
    November 23, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    WHILE PERFORMING AN INVESTIGATION ON THE CUSTOMER'S RETURNED FREESTYLE NAVIGATOR TRANSMITTER, A THERMISTOR CRACK WAS OBSERVED. IT HAS BEEN DETERMINED THAT SOME FREESTYLE NAVIGATOR TRANSMITTERS COULD POTENTIALLY EXHIBIT A CRACK/FRACTURE ON THE PLASTIC HOUSING NEAR THE BATTERY COMPARTMENT, WHICH COULD POTENTIALLY ALLOW MOISTURE TO COME IN CONTACT WITH THE TRANSMITTER'S INTERNAL ELECTRONICS, POTENTIALLY CAUSING THE TRANSMITTER AND THE RECEIVER TO LOSE CONNECTION INTERRUPTING THE CONTINUOUS GLUCOSE RESULTS. ALTHOUGH UNLIKELY, MOISTURE ENTERING THE TRANSMITTER HAS THE POTENTIAL TO GENERATE INACCURATE RESULTS ONLY WITH THE CONTINUOUS GLUCOSE READINGS. THE BUILT-IN FREESTYLE GLUCOSE METER IS NOT IMPACTED BY THIS ISSUE AND THE USER CAN CONTINUE TO USE THE BUILT-IN METER. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    CALLER REPORTED PERFORMA BLOOD GLUCOSE RESULTS OF 295 MG/DL, 225 MG/DL, 141 MG/DL, AND 191 MG/DL WITHIN 1 MINUTE. REPORTED NO ADVERSE EVENT RELATIVE TO DISCREPANCY. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT SENT.

    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 370219

    Patients

    Seq Age Sex Outcome Treatment
    1 068 YR