BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRPHS

    MDR report key: 17965983 · Received October 19, 2023

    Report

    Report Number
    1823260-2023-03350
    Event Type
    Malfunction
    Date Received
    October 19, 2023
    Date of Event
    September 21, 2023
    Report Date
    December 5, 2023
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NQD
    UDI-DI
    04015630921508
    PMA / PMN Number
    K053603
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CALIBRATION AND QC WERE ACCEPTABLE. NO ISSUES WERE IDENTIFIED DURING A REVIEW OF THE ALARM TRACE DATA. THE SAMPLE CONCENTRATION FOR THE PATIENT WAS RELATIVELY HIGH. PRODUCT LABELING STATES: "DETERMINE SAMPLES HAVING HIGHER CONCENTRATIONS VIA THE RERUN FUNCTION. DILUTION OF SAMPLES VIA THE RERUN FUNCTION IS A 1:15 DILUTION." THE CUSTOMER USED A 1:20 DILUTION. THE SAMPLE WAS REPEATED USING "IFI" TECHNOLOGY. DIFFERENT ANALYTICAL METHODS MAY PRODUCE DIFFERENT RESULTS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE EVENT WAS DUE TO A SAMPLE HANDLING ISSUE (NON-VALIDATED DILUTION).

    Additional Manufacturer Narrative · 0

    THE C501 MODULE SERIAL NUMBER WAS (B)(6).

    Description of Event or Problem · 0

    THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR CRPHS ON A COBAS 6000 C501 MODULE. THE INITIAL RESULT WAS 589.14 MG/L ACCOMPANIED BY AN INVALIDATING DATA FLAG. THE SAMPLE WAS REPEATED WITH A 1:20 DILUTION AND THE RESULT WAS 281.10 MG/L. THE SAMPLE WAS THEN REPEATED USING "IFI" TECHNOLOGY AND THE RESULT WAS 137.4 MG/L. THIS RESULT WAS BELIEVED TO BE CORRECT. ON (B)(6) 2023 THE SAMPLE WAS REPEATED AND THE RESULT WAS 580.97 MG/L ACCOMPANIED BY AN INVALIDATING DATA FLAG. THE SAMPLE WAS REPEATED AGAIN WITH A 1:20 DILUTION AND THE RESULT WAS 275.35 MG/L. ADDITIONAL RESULTS WERE PROVIDED FROM 28-SEP-2023: THE RESULT WAS 596.94 MG/L ACCOMPANIED BY AN INVALIDATING DATA FLAG. THE REPEAT RESULT IN DECREASED MODE WAS 272.58 MG/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1738753 CRPHS CARDIAC C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL NQD ROCHE DIAGNOSTICS 72884801 04015630921508

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female CIPROFLOXACIN.