BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CREJ2 CREATININE JAFFE GEN.2 - COMPENSATED METHOD FOR SERUM AND PLASMA

    MDR report key: 11862113 · Received May 21, 2021

    Report

    Report Number
    1823260-2021-01512
    Event Type
    Malfunction
    Date Received
    May 21, 2021
    Date of Event
    April 20, 2021
    Report Date
    June 25, 2021
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CGX
    PMA / PMN Number
    K941837
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THERE IS NO INDICATION OF A GENERAL HARDWARE ISSUE OR ISSUE WITH REAGENT PERFORMANCE. AN INTERFERENCE OF MEDICATION WAS EXCLUDED AS THE CREATININE RESULTS USING DIFFERENT METHODOLOGIES MATCHED AND THE REACTION KINETICS LOOKED NORMAL. THE EVENT WAS CONSISTENT WITH A PRE-ANALYTIC ISSUE AS "ABNORMAL PROBE SUCKING" ALARMS OCCURRED PRIOR TO THE EVENT, THE ACTUAL SAMPLE DRAW VOLUME WAS LOW, AND THE RESULTS WERE CONFIRMED AT A DIFFERENT FACILITY.

    Additional Manufacturer Narrative · 1

    PER PRODUCT LABELING FOR THE ASSAY: ANTIBIOTICS CONTAINING CEPHALOSPORIN LEAD TO SIGNIFICANT FALSE POSITIVE VALUES. THE PATIENT IS BEING TREATED WITH CEFTRIAXONE SODIUM. THE ANALYZER ALARM TRACE CONTAINED ERRORS AT THE TIME OF THE EVENT THAT MAY BE RELATED TO A HARDWARE ISSUE. THERE WERE SEVERAL ERRORS INDICATING CALIBRATION ISSUES AND FLUCTUATING CONTROL RECOVERIES OUTSIDE OF THE ACCEPTABLE RANGE. THE FIELD SERVICE ENGINEER PERFORMED AN INSTRUMENT CHECK. THE INVESTIGATION IS ONGOING. THIS EVENT OCCURRED IN (B)(6). UNIQUE IDENTIFIER (UDI) # (B)(4).

    Description of Event or Problem · 1

    THERE WAS AN ALLEGATION OF INTERFERENCE CAUSING QUESTIONABLE CREJ2 CREATININE JAFFÉ GEN.2 RESULTS FOR ONE PATIENT FROM COBAS 6000 C501 MODULE SERIAL NUMBER (B)(4). THE RESULT FOR THE FIRST SAMPLE TESTED AT 7:14 AM WAS 9.69 MG/DL. THE SAME SAMPLE WAS REPEATED AND THE RESULT WAS 9.67 MG/DL. A NEW SAMPLE WAS TESTED AT 8:33 AM AND THE RESULT WAS 0.46 MG/DL. A THIRD SAMPLE WAS TESTED AT 13:55 PM AND THE RESULT WAS 0.46 MG/DL. THE REPEAT RESULT WAS 0.46 MG/DL. THE SAME SAMPLES WERE SENT TO ANOTHER FACILITY USING THE SAME ASSAY AND THE RESULTS MATCHED FOR EACH SAMPLE. NO SPECIFIC DATA WAS PROVIDED. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758188 CREJ2 CREATININE JAFFE GEN.2 - COMPENSATED METHOD FOR SERUM AND PLASMA ALKALINE PICRATE, COLORIMETRY, CREATININE CGX ROCHE DIAGNOSTICS CREAJ 47624401

    Patients

    Seq Age Sex Outcome Treatment
    1 0.9% SODIUM CHLORIDE| AMBROXOL HCL| AMLODIPINE BESILATE| ASCORBIC ACID| ASPRIN| BUDESONIDE| CEFTRIAXONE SODIUM| COLECALCIFEROL| DEXAMETHASONE SODIUM| DEXTROSE 5%| ENOXAPARIN SODIUM| IPRATROPIUM BROMIDE / SALBUTAMOL SULFATE| LEVOFLOXACIN| PANTOPRAZOLE SODIUM| PARACETAMOL| 0.9% SODIUM CHLORIDE| AMBROXOL HCL| AMLODIPINE BESILATE| ASCORBIC ACID| ASPRIN| BUDESONIDE| CEFTRIAXONE SODIUM| COLECALCIFEROL| DEXAMETHASONE SODIUM| DEXTROSE 5%| ENOXAPARIN SODIUM| IPRATROPIUM BROMIDE / SALBUTAMOL SULFATE| LEVOFLOXACIN| PANTOPRAZOLE SODIUM| PARACETAMOL