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 2018-10-12 for VIDAS? LYME IGG 30320 manufactured by Biomerieux Sa.
[123569460]
A customer in (b)(6) contacted biom? Rieux to report the occurrence a false negative patient result in association with the vidas? Lyme igg assay (ref. 30320). The initial result was 0. 19 (negative); repeat result was 0. 26 (positive). The customer also indicated that qc is inconsistent for the lyme igg assay. There is no indication or report from the laboratory or a physician that the discrepant result led to any adverse event related to the patient's state of health. Biom? Rieux requested strain submittal from the customer. A biom? Rieux internal investigation has been initiated. Note: reference 30320 (vidas lyme igg) is not registered in the united states. The u. S. Similar device is product reference 417401 (vidas lyme igg ii).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2018-00211 |
| MDR Report Key | 7961108 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-10-12 |
| Date of Report | 2018-10-12 |
| Date Mfgr Received | 2018-09-12 |
| Device Manufacturer Date | 2017-12-21 |
| Date Added to Maude | 2018-10-12 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JEFF SCANLAN |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147318694 |
| Manufacturer G1 | BIOMERIEUX SA |
| Manufacturer Street | CHEMIN DE L ORME |
| Manufacturer City | MARCY L ETOILE, RHONE 69280, |
| Manufacturer Country | FR |
| 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 | 2018-10-12 |
| Catalog Number | 30320 |
| Lot Number | 1006179040 |
| Device Expiration Date | 2018-11-25 |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-12 |