BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRPHS CARDIAC C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE

    MDR report key: 6719419 · Received July 17, 2017

    Report

    Report Number
    1823260-2017-01472
    Event Type
    Malfunction
    Date Received
    July 17, 2017
    Date of Event
    June 28, 2017
    Report Date
    August 13, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NQD
    PMA / PMN Number
    K053603
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UNIQUE IDENTIFIER (UDI)#: (B)(4)

    Additional Manufacturer Narrative · 1

    THERE HAVE BEEN NO OTHER ISSUES OF THE SAME NATURE AT THE CUSTOMER SITE WITHIN THE PAST 12 MONTHS. INVESTIGATIONS CONCLUDE THAT THE CAUSE OF THE ISSUE WAS USER ERROR AS THE CUSTOMER USED THE REAGENT PACK PAST THE LABELED ON-BOARD STABILITY DATE OF 12 WEEKS.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY HAVE HAD ISSUES WITH RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED WITH THE CRPHS CARDIAC C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE (CRPHS) ASSAY EVER SINCE INSTALLATION OF THE COBAS 6000 C (501) MODULE - C501 ON APPROXIMATELY (B)(6)2017. THE CUSTOMER PROVIDED DATA FOR FOUR PATIENT SAMPLES WHICH HAD ERRONEOUS INITIAL RESULTS THAT WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLES WERE REPEATED ON THE SAME ANALYZER AND THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT. THE FIRST SAMPLE INITIALLY RESULTED AS 2.93 MG/L AND REPEATED AS 4.83 MG/L. THE SECOND SAMPLE, FROM A (B)(6) YEAR OLD FEMALE, INITIALLY RESULTED AS 5.85 MG/L AND REPEATED AS 8.52 MG/L. THE THIRD SAMPLE, FROM A (B)(6) YEAR OLD MALE, INITIALLY RESULTED AS 3.04 MG/L AND REPEATED AS 5.66 MG/L. THE FOURTH SAMPLE, FROM A (B)(6) YEAR OLD MALE, INITIALLY RESULTED AS 2.94 MG/L AND REPEATED AS 4.68 MG/L. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENTS. THE C501 ANALYZER SERIAL NUMBER WAS (B)(4). TO RESOLVE THE ISSUE, THE CUSTOMER REPLACED THE REAGENT PACK AND CALIBRATED A NEW REAGENT PACK OF A NEW LOT. THE REAGENT PACK THAT WAS IN USE DURING THE TIME OF THE ISSUE HAD BEEN IN USE FOR 6 MONTHS AND HAD CALIBRATION ISSUES. THE STABILITY OF AN OPENED REAGENT PACK IS 12 WEEKS. THE CUSTOMER CALIBRATED AND RAN QUALITY CONTROLS ON A NEW REAGENT PACK; THESE WERE OK. PRECISION STUDIES WERE PERFORMED AND THESE WERE OK. THE FIELD SERVICE ENGINEER RAN MECHANISM CHECKS AND THESE WERE OK. HE CHECKED THE GEAR PUMP AND VACUUM; THESE WERE OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499022 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 66 YR