MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2016-12-05 for VIDAS? TOXO IGM 30202 manufactured by Biomerieux Sa.
[61506007]
A customer in (b)(6) reported to biom? Rieux that they have observed false negative results, as part of eeq ctcb 1632, in association with the vidas? Toxo igm test. The customer indicated the serum is a known positive and the test results were: result obtained : 0. 48 => negative. The test results and ctcb report was requested from the customer. An internal biom? Rieux investigation has been initiated.
Patient Sequence No: 1, Text Type: D, B5
[63945459]
A customer in (b)(6) reported to biom? Rieux that they have observed false negative results, as part of eeq ctcb 1632, in association with the vidas? Toxo igm test. An internal biom? Rieux investigation was performed. Results for this control ctcb toxo 163 are as follows : -four (4) participants gave a positive result as expected, -31 participants gave an equivocal result, -84 participants gave a negative result. Since january 2015, there has been no recurrence on a specific batch of vidas? Toxo igm for an external quality problem. The study of batch history record for vidas? Toxo igm lots 1004881890 / 170306-0, 1004702590 / 161202-0 et 1005939820 / 170507-0 shows no anomaly during the control process. The quality product laboratory observed control charts for five (5) internal samples for six (6) lots of vidas? Toxo igm including lots 170306-0, 161202-0 and 170507-0: all of the results were within expected ranges and all batches were within the trend of the parameter. The quality product laboratory tested the control ctcb toxo 163 and found an equivocal result on vidas? Toxo igm lot 161202-0. The results indicated in the ctcb report were confirmed. Complementary results are indicated in ctcb report for control ctcb toxo 163: -vidas? Toxo igg ii: 95 ui/ml positive (pre-testing result), -vidas? Toxo avidity: 0410 tv high (pre-testing result), -toxo isaga positive (result found by 12/12 participants). A result of avidity higher than 0. 300 indicates an old infection, older than 4 months. Conclusion: probable old infection for control ctcb toxo 163. This control could contain residual igm, which are not detected by the vidas? Technique. In the case of a sample from a patient, it is recommended to collect a second sample, 3 weeks after the first collection, to check the kinetics of igg and confirm the avidity result. This conclusion is aligned with the conclusion proposed by the ctcb in the report. Vidas? Toxo igm lots 1004881890 / 170306-0, 1004702590 / 161202-0 et 1005939820 / 170507-0 are in the expected performances. Anomaly linked to the control ctcb toxo 163, which probably contains residual igm.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2016-00495 |
| MDR Report Key | 6145775 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-12-05 |
| Date of Report | 2016-11-09 |
| Date Mfgr Received | 2016-11-09 |
| Device Manufacturer Date | 2016-05-20 |
| Date Added to Maude | 2016-12-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147317301 |
| Manufacturer G1 | BIOMERIEUX SA |
| Manufacturer Street | CHEMIN DE L ORME |
| Manufacturer City | MARCY L ETOILE, RHONE 69280 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 69280 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VIDAS? TOXO IGM |
| Generic Name | VIDAS? TOXO IGM |
| Product Code | LYR |
| Date Received | 2016-12-05 |
| Catalog Number | 30202 |
| Lot Number | 1004881890 |
| Device Expiration Date | 2017-03-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX SA |
| Manufacturer Address | CHEMIN DE L ORME MARCY L ETOILE, RHONE 69280 FR 69280 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-05 |