MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-20 for VIDAS? MEASLES IGG 30219 manufactured by Biomerieux, S.a..
[63261159]
A customer in (b)(6) notified biom? Rieux of discrepant results associated with the vidas? Measles igg (reference (b)(4)) related to false negative results involving a neqas sample ((b)(6)). An internal biom? Rieux investigation has been initiated.
Patient Sequence No: 1, Text Type: D, B5
[67547892]
This report was initially submitted following notification that a customer in the (b)(6)notified biom? Rieux of discrepant results associated with the vidas measles igg (reference 30219) related to false negative results involving a (b)(6) sample (distribution (b)(6) / specimen (b)(6)). The customer reported the sample was tested on their primary testing platform (novatec), which identified the sample as positive. The customer indicated that subsequent testing of the sample via vidas obtained a result of equivocal (0. 53, <0. 5 would be negative). An internal biom? Rieux investigation was conducted. The thresholds and interpreted results for vidas measles igg assay are the following: < 0. 50 negative, - 0. 50 to < 0. 70 equivocal, - 0. 70 positive. The external quality assessment "eqa msg 3401 from (b)(6) distribution (b)(6)" indicates that 88% of the participants who used vidas measles igg (msg) ref. 30219 obtained equivocal or negative results, though it was expected to be positive. Three (3) similar complaints were recorded for discrepant results using two (2) different vidas msg batches. - vidas msg lot 1004949820 (170430-0) gave an equivocal result (0. 68 tv) ((b)(4)). - vidas msg lot 1004802610 (170302-0) gave an equivocal result (0. 53 tv) ((b)(4)) and a negative result (0. 48 tv) ((b)(4)). Analysis of the associated batch history records shows no anomaly during the manufacturing and control processes. The biom? Rieux quality product laboratory studied the control charts of six (6) internal samples (target : 0. 2 vt, 0. 17 vt, 3. 09 vt, 4. 81 vt, 1. 59 vt and 0. 31 vt) with eight (8) different batches of vidas? Msg including the two (2) customer batches: all results were within specifications. The quality product laboratory also tested the six (6) internal samples with vidas? Msg lots 170302-0 and 170430-0. The results were similar to those obtained during the release of the batches confirming that there is no evolution of the vidas msg lots 170302-0 and 170430-0. The quality product laboratory tested the specimen 3401 from (b)(6) distribution (b)(6) with vidas msg lot 170302-0, lot 170430-0 and an additional batch 170622-0 (batch manufactured with different critical raw material) and obtained the following results: - vidas msg lot 170302-0 ; sample 3401 : 0. 47 tv (584 rfv ) negative interpretation customers' results: 0. 53 tv negative interpretation and 0. 58 vt equivocal interpretation the customer's results and results obtained at the quality product laboratory are very close from the equivocal lower zone (0. 5 tv) for this sample and are reproducible between themselves. It's written in the ifu that "equivocal samples should be repeated with a fresh specimen". - vidas msg lot 170430-0 ; sample 3401 : 0. 66 tv (900 rfv ) equivocal interpretation customers' results: 0. 68 tv equivocal interpretation the customer's results and results obtained at the quality product laboratory are reproducible between themselves. It's written in the ifu that "equivocal samples should be repeated with a fresh specimen". - vidas msg lot 170622-0 ; sample 3401 : 0. 92 tv (1249 rfv) positive interpretation. External quality controls are manufactured samples and not natural samples from patients. Manufacturing process can affect sample matrix. No information was received from (b)(6) regarding the manufacturing of this external quality control. Without this information, it's not possible to investigate further. Furthermore, internal samples close from the equivocal zone have been tested on these three (3) lots during the quality control of these lots and all gave the compliant interpretation, no interpretation change was observed from batch to batch. Based on the complaint trend analysis, on the results obtained on six (6) internal samples retested, on the results obtained on the specimen 3401 from (b)(6)distribution (b)(6) which are close from the equivocal lower zone or within the equivocal zone and on the fact that no information was received from (b)(6) regarding the manufacturing of this external quality control, the investigation concludes that performance of vidas msg lots 170302-0 and 170430-0 are within specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2016-00525 |
| MDR Report Key | 6189139 |
| Date Received | 2016-12-20 |
| Date of Report | 2016-11-30 |
| Date Mfgr Received | 2016-11-30 |
| Date Added to Maude | 2016-12-20 |
| 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 | ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | ST. LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer G1 | BIOMERIEUX, INC |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | ST. LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63042 |
| 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 | 2016-12-20 |
| Catalog Number | 30219 |
| Lot Number | 1004802610 |
| 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, S.A. |
| Manufacturer Address | CHEMIN DE L ORME MARCY L ETOILE, RHONE 69280 FR 69280 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-20 |