VIDAS® CMV IGM
Report
- Report Number
- 3002769706-2017-00275
- Event Type
- Malfunction
- Date Received
- September 7, 2017
- Report Date
- July 17, 2018
- Manufacturer
- BIOMERIEUX, S.A.
- Product Code
- LKQ
- PMA / PMN Number
- K933549
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
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.
A CUSTOMER FROM (B)(6) REPORTED TO BIOMÉRIEUX OUT OF RANGE LOW RESULTS WHEN TESTING THE INTERNAL QUALITY CONTROL VIROTROL FROM BIO-RAD IN ASSOCIATION WITH VIDAS® CMV IGM (LOT 1005685430), WHEN COMPARED TO THE SPECIFICATION THE CUSTOMER PUT IN PLACE, FROM RESULTS BASED ON PREVIOUS LOTS. CALIBRATION VALUES: COMPARTMENT B1 - S1: BDF = 148/1125 RFV [714 - 1548], COMPARTMENT B2 - S1: BDF = 144/1050 RFV, COMPARTMENT B3 - C1: BDF = 144/1614 RFV VT = 1.48 [1.12 - 1.60], COMPARTMENT B4 - C2: BDF = 144 / -6 RFV VT = 0 [<OR = 0.69]. LOT 1005685430 CQI VALUES OBTAINED: (B)(6) 2017: BDF = 144/800 RFV / VT = 0.73 => EQUIVOCAL (NOT CONFORMED), (B)(6) 2017: BDF = 146/863 RFV / VT = 0.79 => EQUIVOCAL (NON-COMPLIANT), (B)(6) 2017: BDF = 150/802 RFV / VT = 0.73 => EQUIVOCAL (NOT CONFORMED), (B)(6) 2017: BDF = 157/920 RFV / VT = 0.82 => EQUIVOCAL (NON-COMPLIANT). RECALIBRATION WITH VORTEXING FOR 20 SECONDS AND INITIATION OF ICQ AFTER HOMOGENIZATION BY 20 TURNS RESULTED IN THE CIQ AS ALWAYS EQUIVOCAL. COMPARTMENT B1 - S1: BDF = 149/1155 RFV, COMPARTMENT B2 - S1: BDF = 150/1269 RFV, COMPARTMENT B3 - C1: BDF = 147/1596 RFV VT = 1.31, COMPARTMENT B4 - C2: BDF = 146 / -9 RFV / VT = -0.00, COMPARTMENT B5 VIROTROL: BDF = 144/970 RFV / VT = 0.80 => EQUIVOCAL. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 628369 | VIDAS® CMV IGM | VIDAS® CMV IGM | LKQ | BIOMERIEUX, S.A. | 1005685430 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |