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 2017-12-01 for VIDAS? LYME IGG 417401 manufactured by Biomerieux Sa.
[94743631]
A customer from the united states notified biom? Rieux of false negative results associated with the vidas? Lyme igg ii involving a patient sample. The customer indicated running the patient sample and getting negative result; however, the sample was sent to a reference lab where the western blot was positive for multiple bands. The customer reported the specimen they tested and the specimen the reference lab tested were obtained from the patient at the same time but were in different tubes. Serum was used for both tests. The customer indicated neither specimen is available for submission to biom? Rieux. A biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2017-00390 |
| MDR Report Key | 7076042 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-12-01 |
| Date of Report | 2018-03-02 |
| Date Mfgr Received | 2018-02-06 |
| Device Manufacturer Date | 2017-04-21 |
| Date Added to Maude | 2017-12-01 |
| 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 | MS. ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | ST. LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer G1 | BIOMERIEUX SA |
| Manufacturer Street | CHEMIN DE L ORME 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 | 2017-12-01 |
| Catalog Number | 417401 |
| Lot Number | 1005659490 |
| Device Expiration Date | 2018-07-10 |
| 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 | 2017-12-01 |