VIDAS® CMV IGM
Report
- Report Number
- 3002769706-2017-00269
- Event Type
- Malfunction
- Date Received
- September 6, 2017
- Report Date
- July 16, 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
BIOMÉRIEUX WAS ABLE TO PERFORM ADDITIONAL TESTING WITH BIORAD VIROTROL INTERNAL QUALITY CONTROL (IQC) SAMPLES IN ASSOCIATION WITH VIDAS® CMV IGM (LOT 1005712890). VIROTROL TORCH IQC LOTS 128620 AND 128630 WERE TESTED ON DIFFERENT 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 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. FURTHER INVESTIGATION INTO THE DETAILS OF THE MANUFACTURING PROCESS AND A 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.
THE CUSTOMER COMPLAINED ABOUT A LOW RESULT OBTAINED WHEN TESTING THE IQC "VIROTROL" FROM BIORAD WITH VIDAS CMV IGM LOT 1005712890/180328-0 (TV : 1.11) COMPARED TO THE SPECIFICATION HE HAD PUT IN PLACE BASED ON RESULTS OBTAINED ON PREVIOUS LOTS. THE ANALYSIS OF THE BATCH HISTORY RECORDS SHOWED NO ANOMALY. THERE IS NO OTHER COMPLAINT RECORDED FOR THE SAME ISSUE ON THE KIT VIDAS CMV IGM LOT 1005712890/180328-0. THERE IS NO NON-CONFORMITY LINKED TO THE CUSTOMER'S ANOMALY ON THIS LOT AND NO CAPA ON THE PRODUCT REFERENCE. (B)(6). THE DIFFERENCES OBSERVED ARE LINKED TO THE NORMAL INTER-LOT VARIABILITY WHICH HAS NO IMPACT ON PATIENT RESULT OR INTERPRETATION STATUS. FURTHERMORE THIS IQC VIROTROL IS MANUFACTURED (NOT NATURAL SAMPLE) AND MANUFACTURING PROCESS CAN AFFECT SAMPLE MATRIX, SO THE HYPOTHESIS IS THAT THIS SAMPLE COULD BEHAVE DIFFERENTLY FOLLOWING SOME LOTS OF VIDAS CMVM. IT IS RECOMMENDED THAT EACH LABORATORY ESTABLISHES ITS OWN RANGE FOR EACH ANALYTE (EXTRACT FROM PACKAGE INSERT VIROTROL TORCH-M). (B)(6). CHECK WITH THE CUSTOMER HOW STATISTICS ARE COMPUTED AND SUGGEST THE CUSTOMER THAT IS ALSO POSSIBLE TO WORK WITH A MOBILE MEAN. THE QUALITY PRODUCT LABORATORY ANALYZED COMPLAINTS ABOUT SENSITIVITY PROBLEM (POTENTIAL FALSE NEGATIVE RESULT) SINCE 2013 AND OBSERVED THAT THERE IS NO INCREASE OF COMPLAINTS. BASED ON COMPLAINTS, THE RELATIVE SENSITIVITY IS ABOUT 99.99 % AND CONFORM TO PACKAGE INSERT PERFORMANCES (SENSITIVITY: 90.24 %) ACCORDING TO THE DATA MENTIONED ABOVE, VIDAS CMV IGM LOT 1005685430/180320-0 IS WITHIN THE EXPECTED SPECIFICATIONS.
A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF LOW OUT OF RANGE RESULTS WHEN TESTING THE INTERNAL QUALITY CONTROL VIROTROL TORCH FROM BIORAD WITH VIDAS® CMV IGM LOT 1005712890: (B)(6). 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 WAS PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 625283 | VIDAS® CMV IGM | VIDAS® CMV IGM | LKQ | BIOMERIEUX, SA | 1005712890 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |