BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1482355 · Received July 16, 2009

    Report

    Report Number
    1823260-2009-04980
    Event Type
    Malfunction
    Date Received
    July 16, 2009
    Date of Event
    July 1, 2009
    Report Date
    February 26, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPARISON STUDY FOR ACETAMINOPHEN WAS PERFORMED DURING THE INVESTIGATION USING 30 PATIENT SERUM SAMPLES. THE CORRELATION SAMPLES WERE ANALYZED BY THREE DIFFERENT ROCHE INSTRUMENTS AND BY A REFERENCE METHOD (LC-MS). THE RESULTS OF THE CORRELATION STUDY SHOWED GOOD CORRELATION BETWEEN THE THREE ROCHE INSTRUMENTS AND WITH THE (LC-MS) REFERENCE METHOD. THE ACETAMINOPHEN ASSAY IS PERFORMING WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    STAPLER MISFIRED. THE SURGEON DOES NOT KNOW. THE NURSE THINKS IT IS THE WAY THE SURGEON PUSHED THE BUTTON ON THE STAPLER. REPRESENTATIVE IS COMING TO RE-EDUCATE. CHANGED STAPLERS AND PROCEEDED WITH SURGERY.

    Description of Event or Problem · 1

    THE USER EXPERIENCED AN ISSUE WITH LOW ACETAMINOPHEN RESULTS COMPARED TO ANOTHER METHOD. THE USER PROVIDED A PT CORRELATION BETWEEN THE ENZYMATIC METHOD AND THE MODULAR P ANALYZER. OF THE 21 SAMPLE RESULTS PROVIDED, 13 WERE FOUND TO BE DISCREPANT. NO SPECIFIC DATE OF TESTING WAS PROVIDED. RESULTS ARE ENZYMATIC RESULT FOLLOWED BY MODULAR RESULT AND ARE IN UG PER ML. SAMPLE: 1: 23, 13. SAMPLE 2: 31, 20. SAMPLE 3: 33, 22. SAMPLE 4: 31, 24. SAMPLE 5: 0, 29. SAMPLE 6: 52, 39. SAMPLE 7: 61, 46. SAMPLE 8: 118, 97. SAMPLE 9: 171, 134. SAMPLE 10: 192, 156. SAMPLE 11: 202, 167. SAMPLE 12: 520, 269. SAMPLE 13: 638, 484. NO INFO WAS PROVIDED TO DETERMINE IF ANY ERRONEOUS RESULTS HAD BEEN REPORTED OR IF ANY PTS WERE ADVERSELY AFFECTED. IF ADDITIONAL INFO IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANALYTICAL P MODULE CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK