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 2015-10-21 for VIDAS? LYME IGG 30320 manufactured by Biomerieux Sa.
[28808430]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[28808431]
On (b)(6) 2015, a french customer contacted biomerieux to inform them they have failed the national quality control organized by biologie perspective on (b)(6) 2015 for the test vidas lyme igg ref. 30320 with the lot 1003560430. The igg result for this sample was expected to be negative.
Patient Sequence No: 1, Text Type: D, B5
[35319001]
Biom? Rieux internal investigation was conducted. The investigation testing included two (2) different lots of vidas? Lyme igg. Results of "negative" were obtained for both lots when testing the biologie prospective 2015 2a specimen. The positive result obtained by the customer could not be reproduced. The vidas? Lyme igg assay is performing in accordance with specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2015-00125 |
| MDR Report Key | 5163878 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2015-10-21 |
| Date of Report | 2015-10-01 |
| Date Mfgr Received | 2015-10-01 |
| Device Manufacturer Date | 2014-12-16 |
| Date Added to Maude | 2015-10-21 |
| 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? LYME IGG |
| Generic Name | VIDAS? LYME IGG |
| Product Code | LSR |
| Date Received | 2015-10-21 |
| Catalog Number | 30320 |
| Lot Number | 1003560430 |
| Device Expiration Date | 2015-10-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2015-10-21 |