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 2016-12-20 for VIDAS? LYME IGG 30320 manufactured by Biomerieux Sa.
[62919862]
A customer from (b)(6), reported to biom? Rieux a false negative result in association with the vidas? Lyme igg test. A patient sample was collected and tested with vidas? Lyme igg and the result was negative. The patient sample was then tested using the western blot technique and the result was positive for lyme igg. The lyme igm test was not performed. Both results were given to the patient. The impact of results to the patient is not known. The customer submitted the test reports to biomerieux for review, however the isolate is not available for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2016-00519 |
| MDR Report Key | 6190529 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-12-20 |
| Date of Report | 2016-11-24 |
| Date Mfgr Received | 2016-11-24 |
| 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 | 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? LYME IGG |
| Generic Name | VIDAS? LYME IGG |
| Product Code | LSR |
| Date Received | 2016-12-20 |
| Catalog Number | 30320 |
| Lot Number | 1005029860 |
| Device Expiration Date | 2017-07-08 |
| Device Availability | N |
| 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 | 2016-12-20 |