BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-REACTIVE PROTEIN (LATEX)

    MDR report key: 2081161 · Received May 9, 2011

    Report

    Report Number
    1823260-2011-02462
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    April 6, 2011
    Report Date
    August 2, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DCN
    PMA / PMN Number
    K073277
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED CONCERNING THE PATIENT. THE PATIENT DIAGNOSES WERE: "EMBOLIC ISCHEMIA, INEFFECTIVE ANTICOAGULATION, HYPERTENSIVE, DIABETES MELLITUS TYPE II, COLON RESECTION." THE PATIENT MEDICATIONS WERE: "DIGITOXIN 0.07 MG 1-0-0, DELIX 5 PLUS 1- 0-1, BELOE ZOK 1-0-1, AMLODIPIN 5 MG 1-0-1, ATACAND 32 MG 1-0-1, EBRANTIL 60 MG 1-0-1, JANUMET 50/1000 1-0-1, FINAMED 5 MG 0-0-1, SIMVASTATIN 40 MG 0-0-1, LANTUS 0-00-44, IE INSULINS RAPID AFTER BZ SOHEMA."

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THE DEVIATIONS IN CRP RESULTS BETWEEN THE ANALYZERS. THE CRP REAGENT FOR THE INTEGRA DIFFERS FROM THE CRP REAGENT FOR THE COBAS C701, WHICH MIGHT BE A REASON FOR THE OBSERVED DIFFERENCE IN THE RESULTS. DURING TESTING OF THE PATIENT'S SAMPLES, EXTREMELY ELEVATED IGM RESULTS AND A KAPPA/LAMBDA RATIO OUTSIDE THE NORMAL RANGE WERE DISCOVERED. THESE RESULTS INDICATE A MONOCLONAL GAMMOPATHY WHICH IS A DOCUMENTED LIMITATION MENTIONED IN PRODUCT LABELING FOR THE ASSAY. THE TURBIDITY PRINCIPLE OF THE CRP LATEX AGGLUTINATION TEST IS STRONGLY INTERFERED WITH BY OTHER PROTEINS IN THE SAMPLE, WHICH MAY CAUSE ADDITIONAL TURBIDITIES. CRP MEASUREMENTS WILL BE REPEATED SEVERAL TIMES IN SYMPTOMATIC PATIENTS. RESULTS SHOULD ALWAYS BE EVALUATED IN CONTEXT WITH THE PATIENT'S CLINICAL STATUS AND ADDITIONAL LABORATORY PARAMETERS SUCH AS LEUKOCYTE COUNT, PROCALCITONIN ETC.

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE C-REACTIVE PROTEIN (CRP) RESULTS FOR TWO SAMPLES FROM ONE PATIENT ON THE COBAS INTEGRA 400 PLUS ANALYZER SERIAL NUMBER (B)(4) WHEN COMPARED TO THE RESULTS FROM THE COBAS C701 ANALYZER TESTED APPROXIMATELY THREE DAYS LATER. SAMPLE 1 RESULT FROM THE INTEGRA WAS 2936.4 MG/L AND THE RESULT FROM THE COBAS C701 WAS 2.41 MG/L. ON (B)(6) 2011, SAMPLE 2 RESULT FROM THE INTEGRA WAS 2918.0 MG/L AND THE RESULT FROM THE COBAS C701 WAS 18.4 MG/L. NO ADVERSE EVENTS WERE ALLEGED REGARDING THE ISSUE. THE DOCTOR STATED THE CRP RESULTS FROM THE COBAS C701 REVEAL THE CORRECT VALUES AS THE PATIENT LEUCOCYTES AND INTERLEUKIN 6 RESULTS WERE WITHIN THE NORMAL RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-REACTIVE PROTEIN (LATEX) SYSTEM, TEST, C-REACTIVE PROTEIN DCN ROCHE DIAGNOSTICS NA 639215

    Patients

    Seq Age Sex Outcome Treatment
    1 067 YR