BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® CMV IGM

    MDR report key: 7666114 · Received July 6, 2018

    Report

    Report Number
    3002769706-2018-00097
    Event Type
    Malfunction
    Date Received
    July 6, 2018
    Report Date
    September 11, 2018
    Manufacturer
    BIOMERIEUX SA
    Product Code
    LKQ
    PMA / PMN Number
    K933549
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE 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 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 THE (B)(6) CONTACTED BIOMÉRIEUX TO REPORT THE OCCURRENCE OF A FALSE NEGATIVE RESULT FOR A NEQAS SURVEY SAMPLE (DISTRIBUTION (B)(4) SAMPLE (B)(6)) IN ASSOCIATION WITH THE VIDAS® CMV IGM ASSAY. THE VIDAS® CMV IGM ASSAY LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. THE CUSTOMER STATED THE NEQAS SAMPLE WAS NOT GRADED DUE TO DIFFICULTY OBTAINING THE EXPECTED RESULT BY MOST SURVEY PARTICIPANTS. THE SAMPLE IS NO LONGER AVAILABLE AT THE CUSTOMER SITE. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY OR PHYSICIAN THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. THERE WAS NO PATIENT DIRECTLY ASSOCIATED WITH THE SURVEY SAMPLE. ALTHOUGH PRODUCT REFERENCE 30205 IS NOT SOLD/DISTRIBUTED IN THE UNITED STATES, A SIMILAR PRODUCT IS (REFERENCE 30205-01). BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507804 VIDAS® CMV IGM VIDAS® CMV IGM LKQ BIOMERIEUX SA 30205-01

    Patients

    Seq Age Sex Outcome Treatment
    1