MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-02-12 for VIDAS? MEASLES IGG 30219 manufactured by Biomerieux Sa.
[38142595]
A customer at "(b)(6)" reported discrepant results in three patients with measles while using; vidas? Measles igg test.
Patient Sequence No: 1, Text Type: D, B5
[46266753]
A customer in the united states reported discrepant results associated with vidas? Measles igg test lot 1003910510 and another method (quest). Results of the internal biom? Rieux investigation are as follows: the analysis of the batch history records showed no anomaly, but some positive sera were found outside of the internal norms; however, without changing of serological interpretations. No other complaint was recorded for vidas? Measles igg lot 1003910510/160213-0. No possibility to test samples due to the expiration of vidas? Measles igg lot 1003910510/160213-0 as of 13feb2016. Vidas? Measles igg performance does not claim 100% in terms of specificity or sensitivity. Without the quest performance data (sensitivity and specificity) and the lack of a third method, it is not possible to determine which result is correct between the two (2) methods. In conclusion, no product problem was identified for vidas? Measles igg lot 1003910510/160213-0.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2016-00033 |
| MDR Report Key | 5434235 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-02-12 |
| Date of Report | 2015-10-16 |
| Date Mfgr Received | 2015-10-16 |
| Device Manufacturer Date | 2015-04-13 |
| Date Added to Maude | 2016-02-12 |
| 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 | MR. RYAN LEMELLE |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147318582 |
| 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? MEASLES IGG |
| Generic Name | VIDAS? MEASLES IGG |
| Product Code | LJB |
| Date Received | 2016-02-12 |
| Catalog Number | 30219 |
| Lot Number | 1003910510 |
| Device Expiration Date | 2016-02-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2016-02-12 |