VIDAS® CMV IGM
Report
- Report Number
- 3002769706-2017-00273
- Event Type
- Malfunction
- Date Received
- September 6, 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
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 IN (B)(6) NOTIFIED BIOMÉRIEUX OF LOW OUT OF RANGE ACCURUN 26 INTERNAL QUALITY CONTROL RESULTS FOR VIDAS® CMV IGM, LOT 1005712890. CALIBRATION CMVM - COMPLIANCE ((B)(6) 2017): S1: BDF = 139 RFV = 1225, BDF = 142 RFV = 1377, [728-1577 RFV]. C1: COMPARTMENT A3 BDF = 135 RFV = 1696 RESULT = 1.30 POSITIVE, [1.16-1.65]. C2: COMPARTMENT B1 BDF = 144 RFV = -6 RESULT = 0.00 NEGATIVE, [<OR = 0.69]. ACCURUN 26 CALIBRATION RESULT: ONE / COMPARTMENT C1 BDF = 146 RFV = 1531 RESULT = 1.17 POSITIVE, [1.21 - 1.48] MEAN = 1.34. CALIBRATION CMVM - COMPLIANCE ((B)(6) 2017): S1: BDF = 145 RFV = 1173, BDF = 147 RFV = 1079, [728-1577 RFV]. C1: BDF = 148 RFV = 1568 RESULT = 1.39 POSITIVE, [1.16-1.65]. C2: BDF = 145 RFV = -4 RESULT = 0.00 NEGATIVE, [<OR = 0.69]. ACCURUN 26 CALIBRATION RESULT: ONE / COMPARTMENT C2 BDF = 148 RFV = 94 RESULT = 0.08 NEGATIVE, [1.21 - 1.48] AVERAGE = 1.34 => (ERROR SUSPECTED BY CUSTOMER). TWO / COMPARTMENT A1 BDF = 142 RFV = 1751 RESULT = 1.55 POSITIVE, [1.21 - 1.48] MEAN = 1.34. 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 |
|---|---|---|---|---|---|---|---|
| 626820 | VIDAS® CMV IGM | VIDAS® CMV IGM | LKQ | BIOMERIEUX, SA | 1005712890 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |