VIDAS® TOXO IGG II
Report
- Report Number
- 8020790-2019-00012
- Event Type
- Malfunction
- Date Received
- February 11, 2019
- Date of Event
- December 24, 2018
- Report Date
- May 17, 2019
- Manufacturer
- BIOMERIEUX SA
- Product Code
- LGD
- PMA / PMN Number
- K993319
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
SECTION B2: CHECKMARK NEXT TO "REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE" WAS ERRONEOUSLY CHECKED IN THE PREVIOUS REPORT. CHECKMARK REMOVED.
AN INTERNAL INVESTIGATION WAS PERFORMED FOR A CUSTOMER IN FRANCE REPORTING FALSE POSITIVE RESULTS FOR A PREGNANT FEMALE PATIENT, WHEN USING TWO LOTS (1006807940 & 1006597880 ) OF VIDAS® TOXO IGG II 60 TESTS (REF. 30210). THE CUSTOMER SUBMITTED THE ISOLATE FOR EVALUATION. A REVIEW OF QUALITY RECORDS CONFIRMED: NO OTHER SIMILAR COMPLAINT WAS RECORDED ON VIDAS TOXO IGG II, LOT 1006807940/190810-0, AND ON LOT 1006597880/190509-0. NO CAPA (CORRECTIVE ACTION PREVENTIVE ACTION) NOR NON-CONFORMITY LINKED TO THE CUSTOMER'S COMPLAINT WAS RECORDED ON VIDAS TOXO IGG II, REF 30210. ANALYSIS OF BOTH BATCHES HISTORY RECORDS SHOWS NO ANOMALY DURING THE MANUFACTURING, CONTROL AND PACKAGING PROCESSES. A STUDY OF INTERNAL SAMPLE CONTROL CHARTS OF THREE INTERNAL NEGATIVE SAMPLES AND ONE INTERNAL POSITIVE SAMPLE WERE OBSERVED ON SIX DIFFERENT LOTS OF VIDAS TOXO IGG II INCLUDING THE CUSTOMER'S TWO LOTS. ALL THE RESULTS OBSERVED WERE WITHIN THE EXPECTED SPECIFICATIONS. VIDAS TOXO IGG II, LOT 1006807940/190810-0 AND LOT 1006597880/190509-0 ARE IN THE TREND OF THE OTHER LOTS. TESTING OF INTERNAL SAMPLES: FOUR INTERNAL SAMPLES WERE TESTED ON VIDAS TOXO IGG II, LOT 1006807940/190810-0 AND LOT 1006597880/190509-0, AND ALL THE RESULTS CONFORMED TO EXPECTED SPECIFICATIONS. THE RESULTS WERE SIMILAR TO THOSE OBTAINED BEFORE THE BATCHES' RELEASE. THERE WAS NO DRIFT OF THE LOTS SINCE THE BATCHES' RELEASE. TESTING OF CUSTOMER'S SAMPLE 30404962 : ON VIDAS TOXO IGG II, LOT 1006807940/190810-0: 17UI/ML (POSITIVE). ON VIDAS TOXO IGG II, LOT 1006597880/190509-0: 14UI/ML (POSITIVE). THE CUSTOMER'S RESULTS WERE REPRODUCED ON BOTH LOTS. INTERFERENCE RESEARCH: WAALER ROSE SLIDE TEST IS CLEARLY POSITIVE, AND ALLOWED IDENTIFICATION OF THE PRESENCE OF RHEUMATOID FACTORS. CONCLUSION: THE CUSTOMER'S SAMPLE ((B)(6)) REPRODUCED THE SAME RESULTS (POSITIVE) WITH VIDAS TOXO IGG II, LOT 1006807940/190810-0, AND LOT 1006597880/190509-0. THE MAIN HYPOTHESIS TO EXPLAIN THIS FALSE POSITIVE RESULT WITH VIDAS TOXO IGG II, MAY BE LINKED TO THE PRESENCE OF AN INTERFERENCE IN THIS PARTICULAR SAMPLE . ACCORDING TO THE PACKAGE INSERT , LIMITATIONS OF THE METHOD, (7). "INTERFERENCE MAY BE ENCOUNTERED WITH CERTAIN SERA CONTAINING ANTIBODIES DIRECTED AGAINST REAGENT COMPONENTS. FOR THIS REASON, ASSAY RESULTS SHOULD BE INTERPRETED TAKING INTO CONSIDERATION THE PATIENT HISTORY, AND THE RESULTS OF ANY OTHER TESTS PERFORMED." ACCORDING TO THE INFORMATION ABOVE, TOXO IGG II 1006807940/190810-0 AND LOT 1006597880/190509-0 ARE WITHIN EXPECTED PERFORMANCES.
A CUSTOMER IN (B)(6) REPORTED (B)(6) RESULTS FOR A PREGNANT FEMALE PATIENT, WHEN USING TWO LOTS (1006807940 AND 1006597880 ) OF VIDAS TOXO IGG II 60 TESTS (REF. (B)(4). RESULTS FROM 22-SEP-2018: TOXO IGG CENTAUR: 0 UI/ML (THRESHOLD 10). THE RESULT WAS (B)(6). TOXO IGM: 0.34 VT (THRESHOLD 0.9). THE RESULT WAS (B)(6). RESULTS FROM 27-OCT-2018: TOXO IGG CENTAUR: 0 UI/ML (THRESHOLD 10). THE RESULT WAS (B)(6). TOXO IGM: 0.25 VT (THRESHOLD 0.9). THE RESULT WAS (B)(6). RESULTS FROM 22-NOV-2018: VIDAS TOXO IGG LOT 1006597880: 14 UI/ML (THRESHOLD 8). THE RESULT WAS (B)(6). VIDAS TOXO IGM : 0.06 VT THE RESULT WAS (B)(6). THE CONCLUSION WAS THAT THE SEARCH OF A PRIMARY TOXOPLASMIC INFECTION WAS REQUIRED TO CONCLUDE THE ANALYSIS, USING THE SAME TECHNIQUE OF TWO SERA TAKEN AT 2-3 WEEKS APART. THE SAMPLE WAS SENT TO (B)(6) LABORATORY ON (B)(6) 2018 AND THE FOLLOWING RESULTS WERE OBTAINED: IGG (FUMOUZE METHOD): 0 (THRESHOLD 8 UI/ML). THE RESULT WAS (B)(6). IGG (PLATELIA BIORAD METHOD): 0 (THRESHOLD 9 UI/ML). THE RESULT WAS (B)(6). IGM (PLATELIA BIORAD MEHOD) : 0.1 (THRESHOLD 1). THE RESULT WAS (B)(6). IGM ISAGA: 6. ALL THESE TESTS WERE COMPLETED BY A WESTERN BLOT AGAINST TOXOPLASMA WHICH WAS (B)(6). THE CONCLUSION WAS ABSENCE OF SPECIFIC IGG, EQUIVOCAL REACTION WITH IGM - PROBABLY NONSPECIFIC. THIS CONCLUSION HAS TO BE CONFIRMED BY A COMPARATIVE TEST 2 WEEKS AFTERWARDS. A NEW SAMPLE WAS COLLECTED ON (B)(6) 2018 AND TESTED BY THE CUSTOMER ON VIDAS: VIDAS TOXO IGG (LOT 1006807940: 17 UI/ML (THRESHOLD 8). THE RESULT WAS (B)(6). VIDAS TOXO IGM : 0.05 VT (THRESHOLD 0.65). THE RESULT WAS (B)(6). ON (B)(6) 2018, THE SERUM FROM THE (B)(6) 2018 WAS ALSO RE-TESTED AND GAVE : VIDAS TOXO IGG LOT 1006807940: 15 UI/ML (THRESHOLD 8). THE RESULT WAS (B)(6). VIDAS TOXO IGM : 0.05 VT (THRESHOLD 0.65). THE RESULT WAS (B)(6). THE SAMPLE OF (B)(6) 2018 WAS SENT TO COCHIN LABORATORY ON (B)(6) 2018 AND THE FOLLOWING RESULTS WERE OBTAINED: IGG (FUMOUZE METHOD): 0 (THRESHOLD 8 UI/ML). THE RESULT WAS (B)(6). IGG (PLATELIA BIORAD METHOD): 0 (THRESHOLD 9 UI/ML). THE RESULT WAS (B)(6). IGM (PLATELIA BIORAD MEHOD) : 0.1 (THRESHOLD 1). THE RESULT WAS (B)(6). IGM ISAGA: 0. THE CONCLUSION WAS THAT THE PATIENT WAS NOT IMMUNIZED AGAINST TOXOPLASMOSIS. THEREFORE, THE VIDAS TOXO IGG GAVE THREE (B)(6) RESULTS WHEREAS ALL THE OTHER METHODS AND TESTS GAVE (B)(6) RESULTS. IT IS NOT KNOWN IF THE (B)(6) RESULTS LEAD TO PATIENT IMPACT. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMERIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. A BIOMERIEUX INTERNAL INVESTIGATION WILL BE INITIATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 121365 | VIDAS® TOXO IGG II | VIDAS® TOXO IGG II | LGD | BIOMERIEUX SA | 1006807940 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |