BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRPHS CARDIAC C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE

    MDR report key: 6102122 · Received November 15, 2016

    Report

    Report Number
    1823260-2016-01772
    Event Type
    Malfunction
    Date Received
    November 15, 2016
    Date of Event
    October 27, 2016
    Report Date
    January 11, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NQD
    PMA / PMN Number
    K053603
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED. A SPECIFIC ANALYZER ISSUE WAS NOT SUSPECTED AS THE ISSUE OCCURRED ON MULTIPLE ANALYZERS. THE PROVIDED REACTION MONITORS DID NOT INDICATE ANY ISSUES. ANY INTERFERENCE FROM THE PATIENT'S MEDICATION WAS EXCLUDED. AN INTERFERENCE FROM A GAMMOPATHY WAS POSSIBLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS EVENT OCCURRED IN (B)(6). EXPIRATION DATE WAS PROVIDED AS "02/2018."

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE CRPHS CARDIAC C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE RESULTS FOR ONE PATIENT WHEN DILUTIONS WERE PERFORMED. THE CUSTOMER USED A COBAS 6000 C (501) MODULE. THE SERIAL NUMBER OF THE ANALYZER WAS REQUESTED, BUT IT WAS NOT PROVIDED. THE UNDILUTED RESULT WAS 149.32 MG/L WITH A DATA FLAG. WITH A 1:3 DILUTION, THE RESULT WAS 51.86 MG/L WITH A DATA FLAG. WITH A 1:5 DILUTION, THE RESULT WAS 14.66 MG/L WITH A DATA FLAG. WITH A 1:10 DILUTION, THE RESULT WAS 0.00 MG/L. WITH A 1:20 DILUTION, THE RESULT WAS 0.00 MG/L. WITH A 1:50 DILUTION, THE RESULT WAS 0.00 MG/L. THE SAMPLE WAS REPEATED ON COBAS 8000 C 702 MODULE. THE SERIAL NUMBER OF THE ANALYZER WAS REQUESTED, BUT IT WAS NOT PROVIDED. THE UNDILUTED RESULT WAS 203.41 MG/L WITH A DATA FLAG. WITH A 1:3 DILUTION, THE RESULT WAS 71.51 MG/L WITH A DATA FLAG. WITH A 1:5 DILUTION, THE RESULT WAS 19.07 MG/L. WITH A 1:10 DILUTION, THE RESULT WAS 0.00 MG/L. WITH A 1:20 DILUTION, THE RESULT WAS 0.00 MG/L. THE RESULT OF 51.68 MG/L WAS REPORTED TO THE PHYSICIAN. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE CUSTOMER HAD NO PROBLEMS WITH OTHERS ASSAYS OR PATIENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754202 CRPHS CARDIAC C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE CARDIAC C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL NQD ROCHE DIAGNOSTICS NA 138687

    Patients

    Seq Age Sex Outcome Treatment
    1 AMLOPINE| CALTRATE PLUS| CELEBREX| COZAAR| FOLIC ACID| FORTEO INJECTION| FORTEO INJECTION| INN (100 MG) TABLET| MICROFIN PENFILL| MOTITIUM| PARADINE TABLET| PREDNISOLONE| RIFAMPICIN| ULTRACET