BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® CMV IGM

    MDR report key: 6852350 · Received September 8, 2017

    Report

    Report Number
    3002769706-2017-00277
    Event Type
    Malfunction
    Date Received
    September 8, 2017
    Report Date
    July 17, 2018
    Manufacturer
    BIOMERIEUX, SA
    Product Code
    LKQ
    PMA / PMN Number
    K933549
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS PERFORMED FOR IQC (INTERNAL QUALITY CONTROL) LOW RESULTS RELATED TO VIROTROL TORCH M AND INGEN ACCURUN QC MATERIALS WHEN USING VIDAS CMVM LOTS 1005685430/180320-0, 1005712890/180328-0, 1005756380/180413-0 AND 1005824730/180524-0. THE ACCURUN QC MATERIAL WAS NOT AVAILABLE FOR TESTING. THE IQC VIROTROL TORCH 18620 WAS FIRST TESTED ON FOUR IMPACTED CUSTOMER BATCHES (1005685430/180320-0, 1005712890/180328-0, 1005756380/180413-0 AND 1005824730/180524-0), AND THREE REFERENCE BATCHES. THE IQC INTERPRETATION WAS STILL POSITIVE OR EQUIVOCAL ALTHOUGH A DECREASE OF THE INDEX TV WAS OBSERVED ON THE FOUR LOTS. A RETAINED KIT OF VIDAS CMV IGM (LOT 1005824730/180524-0), WAS TESTED WITH INTERNAL SAMPLES AND SEROCONVERSION SAMPLES. THERE WAS A DECREASE OF THE INDEX (TV) FOR SEROCONVERSION SAMPLES AND FOR SOME INTERNAL SAMPLES COMPARED TO THE TARGET WITHOUT ANY INTERPRETATION CHANGE. ADDITIONAL TESTING INCLUDED VIROTROL TORCH IQC LOTS 128620 AND 128630 WITH BATCHES OF VIDAS CMVM (1005685430, 1005712890, 1005756380, AND 1005824730). A SIMILAR TV DECREASE WITH BOTH IQC (VIROTROL) LOTS GAVE A POSITIVE OR AN EQUIVOCAL INTERPRETATION DEPENDING ON THE BATCH TESTED. RESULTS OBSERVED IN THE CUSTOMERS LABORATORIES WERE REPRODUCED. RESULTS: VIROTROL TORCH M LOT 128620 : FROM INDEX 1.61 TO TV 1.09 VIROTROL TORCH M LOT 128630 : FROM INDEX 1.24 TO TV 0.78 TWO POSITIVE SAMPLES WITH A TARGET CLOSE TO THE CUT OFF WERE TESTED ON THE SAME BATCHES MENTIONED ABOVE. THEY GAVE VALUES CLOSE TO THEIR EXPECTED TARGET AND GAVE A POSITIVE INTERPRETATION. THE DECREASE AND INTERPRETATION CHANGES WITH NATURAL SAMPLES FROM PATIENTS WERE NOT REPRODUCED. THE INVESTIGATION AND ASSOCIATED CAPA, IDENTIFIED THE ROOT CAUSE AS AN ISSUE WITH THE EQUIPMENT USED FOR THE SONICATION OF THE AG (AGGRAVATING FACTOR) USED AT THE MANUFACTURING SITE. A DECREASE OF EFFICIENCY WAS OBSERVED DURING THE FRAGMENTATION OF THE ANTIGEN. A NEW SONICATOR WAS PUT IN PLACE, AND CURRENT LOTS PRODUCED ARE FOLLOWED UP USING AN ADDITIONAL CONTROL FOR SIX MONTHS IN ORDER TO CHECK THE EFFICIENCY OF THE IMPROVEMENT.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF LOW OUT OF RANGE RESULTS WHEN TESTING THE INTERNAL QUALITY CONTROL BIORAD TORCH WITH VIDAS® CMV IGM, LOT 1005756380. THE VALUE OBTAINED WAS 0.97 FOR SET RANGE OF 1.188 / 1.658. CALIBRATION WAS WITHIN THE RANGE, BUT IN THE LOWER BOUNDARY FOR C1: S1: 1077/1179 RFV, C1: 1312 RFV / VT=1.19 ( RANGE 1.11-1.59 VT). CALIBRATION WAS REPEATED TWICE, AND THE CONTROL C1 WAS HIGHER BUT THE CIQ WAS STILL TOO LOW: S1 1024:1074, C1 1538 RFV / VT= 1.46, CQI 1.00 TOO LOW. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. THERE WAS NO PATIENT ASSOCIATED WITH THIS DISCREPANT QUALITY CONTROL RESULT. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631395 VIDAS® CMV IGM VIDAS® CMV IGM LKQ BIOMERIEUX, SA 1005756380

    Patients

    Seq Age Sex Outcome Treatment
    1