VIDAS® LYME IGG
Report
- Report Number
- 8020790-2019-00050
- Event Type
- Malfunction
- Date Received
- August 23, 2019
- Report Date
- October 29, 2019
- Manufacturer
- BIOMERIEUX SA
- Product Code
- LSR
- PMA / PMN Number
- K122986
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION BY A CUSTOMER IN THE UNITED KINGDOM REGARDING DISCREPANT RESULTS WHILE PERFORMING QUALITY CONTROL (QC) TESTING WITH THE VIDAS® LYME IGG 60 TESTS (REFERENCE:(B)(4), LOTS: 1007086220 AND 1006940510). THE CUSTOMER HAD AN ISSUE WITH THEIR THIRD-PARTY SAMPLE BEING LOWER THAN IT SHOULD BE WITH TWO (2) DIFFERENT LOT NUMBERS OF REAGENT VIDAS LYME IGG (REF. 30320), IN COMPARISON WITH RESULTS OBTAINED WITH PREVIOUS LOT: 1006756630 (LOT NOW EXPIRED). LOT: 1006940510, (REFERENCE: (B)(4), MEDWATCH 8020790-2019-00050). LOT: 1007086220, (REFERENCE: (B)(4), MEDWATCH 8020790-2019-00055). THE CUSTOMER DID NOT COMPLY WITH BIOMÉRIEUX'S REQUEST FOR SAMPLE SUBMISSION. BIOMÉRIEUX INTERNAL INVESTIGATION WAS CONDUCTED. QUALITY CONTROL RECORDS: THE ANALYSIS OF VIDAS LYME IGG BATCH: 1006940510/ 191107-0 SHOWN NO ANOMALY DURING THE MANUFACTURING , CONTROL AND PACKAGING PROCESSES . THE ANALYSIS OF VIDAS LYME IGG BATCH: 1007086220/ 200117-0 SHOWN NO ANOMALY DURING THE MANUFACTURING , CONTROL AND PACKAGING PROCESSES. NO CAPA (CORRECTIVE ACTION PREVENTIVE ACTION) AND NO NON-CONFORMITY LINKED TO THE CUSTOMER'S ISSUE. INTERNAL CONTROL CHARTS ANALYSIS: ALL THE RESULTS ARE WITHIN SPECIFICATIONS, CUSTOMER'S LOTS: 1006940510 AND 1007086220 ARE IN THE TREND OF THE OTHER LOTS. TESTS PERFORMED: TESTS WERE CONDUCTED WITH THREE (3) INTERNAL POSITIVE SAMPLES WITH WEAK INDICES (TARGETS : 0.27 TV, 0.35 TV, 0.79 TV), ONE (1) INTERNAL NEGATIVE SAMPLE (TARGET : 0.02 TV), AND FOUR (4) DIFFERENT VIDAS LYME IGG LOTS INCLUDING THE CUSTOMERS' LOTS. ALL THE RESULTS WERE WITHIN THE EXPECTED SPECIFICATIONS. NO CHANGES WERE OBSERVED FOR BATCHES: 1006940510 AND 1007086220 SINCE THEIR RELEASE. WITHOUT QC MATERIAL RETURN SAMPLE FOR THIS INVESTIGATION, THE INVESTIGATION OBSERVED PREVIOUS RESULTS OBTAINED ON THE INTERNAL QUALITY CONTROL SAMPLE ACCURUN. THIS INTERNAL QUALITY CONTROL SAMPLE WAS TESTED ON FOUR (4) DIFFERENT BATCHES INCLUDING THE TWO (2) BATCHES MENTIONED BY THE CUSTOMER. ALL THE RESULTS ARE POSITIVE WITH HIGH INDEXES FAR FROM THE CUT-OFF. AS MENTIONED IN VIDAS LYME IGG PACKAGE INSERT, "THE VIDAS LYME IGG (LYG) (REF: (B)(4) ASSAY IS AN AUTOMATED QUALITATIVE TEST INTENDED FOR USE ON THE VIDAS FAMILY OF INSTRUMENTS, FOR THE DETECTION OF IGG ANTIBODIES TO BORRELIA BURGDORFERI SENSU LATO (SL) IN HUMAN SERUM OR PLASMA, TO AID IN THE DIAGNOSIS OF LYME DISEASE. IT IS NOT CLAIMED THE QUANTITATIVE MEASUREMENT OF IGG ANTIBODIES." ACCORDING TO ABOVE DATA, VIDAS LYME IGG LOT: 1006940510 AND LOT: 1007086220 ARE COMPLIANT WITH EXPECTED SPECIFICATIONS.
A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING DISCREPANT RESULTS WHILE PERFORMING QUALITY CONTROL (QC) TESTING WITH THE VIDAS® LYME IGG 60 TESTS (REFERENCE 30320, LOT 1006940510). THE CUSTOMER STATED DISCREPANT QC RESULTS WERE OBSERVED AFTER THEIR VIDAS 3 WAS SERVICED AT THE END OF MAY. GLOBAL CUSTOMER SERVICE REVIEWED THE DATA AND CONFIRMED THE CUSTOMER OBTAINED A LOWER TEST RESULT WITH THIS LOT. AS THERE IS NO PATIENT ASSOCIATED WITH THIS QUALITY CONTROL STRAIN, THERE IS NO ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. BIOMÉRIEUX WILL INITIATE AN INTERNAL INVESTIGATION. NOTE: REFERENCE 30320 IS NOT REGISTERED IN THE UNITED STATES. THE U.S. SIMILAR DEVICE IS PRODUCT REFERENCE 417401 (VIDAS LYME IGG II).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 718996 | VIDAS® LYME IGG | VIDAS® LYME IGG | LSR | BIOMERIEUX SA | 1006940510 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |