BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIAC C-REACTIVE PROTEIN

    MDR report key: 2174434 · Received July 24, 2011

    Report

    Report Number
    1823260-2011-03944
    Event Type
    Malfunction
    Date Received
    July 24, 2011
    Date of Event
    June 29, 2011
    Report Date
    July 20, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NQD
    PMA / PMN Number
    K042485
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER HAD AN INTERMITTENT ISSUE WITH ERRATIC RESULTS FOR MULTIPLE ASSAYS WHEN TESTED ON AN ANALYTICAL P MODULE, SERIAL NUMBER (B)(4). EIGHTEEN PATIENTS WERE INVOLVED IN THE ISSUE. THE ASSAYS INCLUDED CREATININE KINASE, CREATININE, C-REACTIVE PROTEIN, ALANINE AMINOTRANSFERASE, ASPARTATE AMINOTRANSFERASE, AND POTASSIUM. MOST OF THE INITIAL RESULTS DID NOT MATCH THE PATIENT'S PREVIOUS RESULTS AND WERE NOT REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER DID PROVIDE ERRONEOUS C-REACTIVE PROTEIN RESULTS FOR ONE PATIENT THAT WAS REPORTED OUTSIDE THE LABORATORY. THE INITIAL C-REACTIVE PROTEIN RESULT WAS TESTED ON (B)(6) 2011 AND RECOVERED 3.566 MG/DL (ACCOMPANIED BY A DATA FLAG). THE SAMPLE WAS REPEATED, USING THE SAME ANALYZER, ON (B)(6) 2011 AND RECOVERED 7.7 MG/DL. THIS RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE SAMPLE WAS REPEATED AGAIN, USING THE SAME ANALYZER, ON (B)(6) 2011 AND RECOVERED 0.373 MG/DL (ACCOMPANIED BY A DATA FLAG). THE SAMPLE WAS REPEATED A FINAL TIME ON (B)(6) 2011, USING THE SAME ANALYZER, AND RECOVERED 26.216 MG/DL. A CORRECTED REPORT WAS SENT ON (B)(6) 2011 WITH THE 26.2 MG/DL RESULT. THE PATIENT WAS NOT ADVERSELY AFFECTED BECAUSE OF ERRONEOUS RESULTS HAVING BEEN REPORTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED A CLOGGED WATER NOZZLE TUBE WAS THE CAUSE OF THE DISCREPANCIES AND HE CLEANED THE TUBING. THE FIELD SERVICE REPRESENTATIVE VERIFIED ANALYZER OPERATION AND THE CUSTOMER RAN CALIBRATIONS AND QUALITY CONTROL THAT WERE ACCEPTABLE TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIAC C-REACTIVE PROTEIN TINA-QUANT CRP (LATEX) HS TEST SYSTEM NQD ROCHE DIAGNOSTICS NA 63922201

    Patients

    Seq Age Sex Outcome Treatment
    1 095 YR