BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRPHS CARDIAC C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE

    MDR report key: 11387183 · Received February 26, 2021

    Report

    Report Number
    1823260-2021-00595
    Event Type
    Malfunction
    Date Received
    February 26, 2021
    Date of Event
    December 9, 2020
    Report Date
    February 26, 2021
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NQD
    PMA / PMN Number
    K053603
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE QC RECOVERY WAS WITHIN SPECIFICATION. SAMPLES WERE REQUESTED FOR FURTHER INVESTIGATION BUT WERE NOT AVAILABLE. INVESTIGATIONS USING NATIVE SAMPLES WITH CRP CONCENTRATION ABOVE 100 MG/L COULD NOT CONFIRM THE ISSUE AND ALL RESULTS WERE WITHIN SPECIFICATIONS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THIS EVENT OCCURRED IN (B)(6). UNIQUE IDENTIFIER (UDI) # (B)(4).

    Description of Event or Problem · 1

    THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS BETWEEN THE CRPL4 C-REACTIVE PROTEIN GEN.4 AND CRPHS CARDIAC C-REACTIVE PROTEIN HIGH SENSITIVE ASSAYS. FOR ONE PATIENT, THE CRP4 RESULT FROM COBAS 8000 COBAS C 701 MODULE SERIAL NUMBER (B)(4)WAS 72.3 MG/L. THE CRPHS RESULT WITH A 1:15 DILUTION FROM A COBAS 8000 C 502 MODULE WAS 136 MG/L. BOTH VALUES WERE REPORTED TO THE MEDICAL PERSONNEL. IT WAS REQUESTED BUT WAS NOT KNOWN WHICH RESULT WAS BELIEVED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282565 CRPHS CARDIAC C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE CARDIAC C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL NQD ROCHE DIAGNOSTICS NA 470708

    Patients

    Seq Age Sex Outcome Treatment
    1