BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAG®

    MDR report key: 13638717 · Received March 1, 2022

    Report

    Report Number
    9615037-2022-00005
    Event Type
    Malfunction
    Date Received
    March 1, 2022
    Report Date
    April 21, 2022
    Manufacturer
    BIOMERIEUX ITALIA S.P.A.
    Product Code
    JJH
    UDI-DI
    03573026471859
    PMA / PMN Number
    C1 EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A CUSTOMER FROM ISRAEL REPORTED TO BIOMÉRIEUX THAT THEY RECEIVED A FALSE NEGATIVE RESULT FOR A ROUTINE EXTRACTION, A BAL (DILUTED) PATIENT SAMPLE WAS TESTED FOR CMV (RT PCR KIT FROM ALTONA. REF# 021013) USING THE EMAG (REF. 418591, SERIAL NUMBER: (B)(6)). EMAG RUN REPORTS WERE ANALYZED AS NO LOGS WERE AVAILABLE. EMAG EXTRACTION REPORT HIGHLIGHTED THAT THE RESPIRATORY SAMPLE WAS EXTRACTED WITH A FULL AUTOMATED EXTRACTION METHOD (SAMPLE IS TRANSFERRED FROM THE INPUT TUBE TO THE VESSEL). THIS IS NOT RECOMMENDED AS REPORTED IN THE DOCUMENTATION BECAUSE WITH RESPIRATORY SAMPLE SETTING, THERE IS NO PIPETTING THRESHOLD APPLIED DURING SAMPLE TRANSFER. IF THE TRANSFER IS NOT CORRECT, NO ALARM WILL BE ISSUED DURING RUN NOR IN THE RUN REPORT, LEADING TO A RISK OF FALSE NEGATIVE RESULT. THIS IS CORRELATED WITH THE TEST PERFORMED ON THE ELUATE. THE ROOT CAUSE OF THE FALSE NEGATIVE RESULT IS LIKELY DUE TO AN ISSUE DURING EMAG EXTRACTION RUN. WITH THE RESPIRATORY SAMPLE SETTING, NO PIPETTING THRESHOLDS ARE APPLIED, DUE TO THIS, IF THERE ARE ANY ISSUES DURING SAMPLE TRANSFER (I.E. WRONG VOLUME OBTAINED), NO ALERT WILL OCCUR AND THE EMAG SYSTEM WILL CONTINUE TO PROCESS THE SAMPLES. THIS FUNCTIONALITY IS DESCRIBED IN EMAG EXTRACTION METHOD USER MANUAL (REF.161150-730 D), AND EMAG USER MANUAL (REF.161150-643 D) - PROVIDED TO EACH USER: 'THE "OTHER" MATRICE IS PART OF THE FLEXIBILITY OF THE SYSTEM ALLOWING A LABORATORY EXTRACTION ON A WIDE RANGE OF SPECIMENS, REGARDLESS OF THE LIQUID CLASS (STILL PIPETTABLE). PIPETTING OF SAMPLES IN THE "OTHER" CATEGORY WILL BE PERFORMED WITHOUT PRESSURE MONITORING, THEREFORE WITHOUT PIPETTING ALARM. AS CONSEQUENCE OF THE DISABLED PIPETTING ALARM, SAMPLE VISCOSITY WILL NOT BE MEASURED AND CLOG PRESENCE WILL NOT BE DETECTED. THEREFORE, SAMPLE PIPETTED VOLUME MIGHT NOT BE ACCURATE. NO ANOMALY WILL BE TRACED IN THE RUN REPORT. IT IS THE RESPONSIBILITY OF THE LABORATORY TO VALIDATE SPECIMENS ASSOCIATED WITH THE "OTHER" CATEGORY.". FIELD SERVICE REVIEWED THIS PROCESS WITH THE CUSTOMER. AS PART OF CONTINUOUS IMPROVEMENT, THE NEXT KNOWLEDGE BASE WILL BE RELEASED WITH PIPETTING THRESHOLD FOR RESPIRATORY SAMPLES. THIS WILL ALLOW FOR AUTOMATIC TRANSFER ON THIS SAMPLE TYPE, WITH AN ALARM TRIGGERED IN CASE OF INCORRECT TRANSFER.

    Description of Event or Problem · 0

    ON (B)(6) 2022 A CUSTOMER FROM (B)(6) REPORTED TO BIOMÉRIEUX THAT THEY RECEIVED A POTENTIAL FALSE NEGATIVE RESULT FOR A ROUTINE EXTRACTION, A BAL (DILUTED) PATIENT SAMPLE WAS TESTED FOR CMV (RT PCR KIT FROM ALTONA. REF# 021013) USING THE EMAG (REF. 418591, SERIAL NUMBER: (B)(4). THE LAB RAN ANOTHER EXTRACTION FROM THE SAME SAMPLE WITH POSITIVE RESULT. THE LAB CHECKED THE ELUATE FOR OTHER HOUSE KEEPING GENES AND IT'S SEEMS THAT NO EXTRACTION MADE FOR THIS SPECIFIC TUBE (SAMPLE NUMBER 8500751), SO IT MIGHT BE AN INCIDENCE OF FALSE NEGATIVE. NO WARNING WERE SHOWN DURING THE RUN. THE LAB MANAGER HAS REPORTED OF A WEIRD NOISE COMING OUT OF THE INSTRUMENT THAT DAY BUT WAS NOT SURE IF IT WAS RELATED. THE NOISE WAS NOT IDENTIFIED BY THE FIELD SERVICE EXPERT (FSE) AND STOPPED SPONTANEOUSLY. GLOBAL CUSTOMER SERVICE (GCS) WAS ABLE TO REVIEW THE PARTIAL LOGS PROVIDED BY THE CUSTOMER. THE LOGS SHOWED THAT THE CUSTOMER WAS RUNNING SAMPLES USING AN AUTOMATIC WORKFLOW INCLUDING THE TRANSFER OF THE SAMPLE FROM THE PRIMARY TUBES TO THE VESSEL ON SAMPLES SET AS RESPIRATORY IN THE SOFTWARE. ACCORDING TO GCS, THIS IS NOT SOMETHING RECOMMENDED BECAUSE AS RESPIRATORY SAMPLES ARE VERY HETEROGENEOUS IN TERM OF VISCOSITY, NO PIPETTING THRESHOLDS ARE APPLIED DURING THE TRANSFER. IT MEANS THAT IS THE SAMPLE IS NOT CORRECTLY TRANSFERRED, THE SYSTEM WILL NOT DETECT IT, AND WILL GIVE A VALID EXTRACTION RESULTS WHILE IT IS NOT THE CASE. THIS INFORMATION IS INDICATED IN THE USER MANUAL, "DUE TO HIGH VISCOSITY SPECIMENS, PIPETTING OF RESPIRATORY SPECIMENS WILL BE PERFORMED WITHOUT PRESSURE MONITORING, SO WITHOUT PIPETTING ALARM. AS CONSEQUENCE OF THE DISABLED PIPETTING ALARM, SAMPLE VISCOSITY WILL NOT BE MEASURED AND CLOG PRESENCE WILL NOT BE DETECTED. THEREFORE, SAMPLE PIPETTED VOLUME MIGHT NOT BE ACCURATE. NO ANOMALY WILL BE TRACED IN THE RUN REPORT. BIOMÉRIEUX VALIDATED EXTRACTION METHODS FOR RESPIRATORY SPECIMENS USE THE ¿OFF-BOARD LYSIS¿ METHOD, MEANING SPECIMENS ARE PIPETTED AFTER LYSIS OPERATION, WITH THE NUCLISENS LYSIS BUFFER VISCOSITY COMPATIBLE WITH INSTRUMENT REQUIREMENTS. IT IS THE RESPONSIBILITY OF THE LABORATORY TO VALIDATE SPECIMENS ASSOCIATED WITH THE "RESPIRATORY" CATEGORIES, USING ON-BOARD LYSIS EXTRACTION METHODS". THE CUSTOMER STATED THAT A TRANSPLANTED PATIENT RECEIVED NEGATIVE CMV RESULTS WHEN THEY WERE INFECTED. THE WRONG RESULTS WERE REPORTED TO THEY PHYSICIAN; HOWEVER, THE PHYSICIAN ASKED THE LAB TO REPEAT THE TESTING BASED ON THE PATIENT'S SYMPTOMS. THERE IS NO INDICATION THAT THE PATIENT WAS HARMED OR TREATED INCORRECTLY. THE FALSE NEGATIVE RESULTS DID LEAD TO A DELAY OF APPROXIMATELY 48 HOURS BECAUSE THE LAB HAD TO PERFORM THE RETEST. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1011855 EMAG® EMAG® JJH BIOMERIEUX ITALIA S.P.A. 418591 03573026471859

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown