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 2019-01-03 for VIDAS? LYME IGG 30320 manufactured by Biomerieux Sa.
[132782904]
On (b)(6) 2018, a customer in (b)(6) reported false negative results when using the vidas? Lyme igg assay, lot 1006571330. The customer stated they obtained vidas? Lyme igg assay negative results for a (b)(6) year-old male patient 's samples with the impacted lot when performing repeat testing in (b)(6) 2018. The customer sent the patient samples to two external laboratories, and the results were positive. There is no indication or report from the hospital or treating physician to biom? Rieux that the discrepant result led to any adverse event related to the patient's state of health. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020790-2019-00001 |
| MDR Report Key | 8214200 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-01-03 |
| Date of Report | 2019-03-21 |
| Date Mfgr Received | 2019-02-21 |
| Device Manufacturer Date | 2018-06-14 |
| Date Added to Maude | 2019-01-03 |
| 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 | MS. CANDACE MARTIN |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| 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 | 2019-01-03 |
| Catalog Number | 30320 |
| Lot Number | 1006571330 |
| 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 | 2019-01-03 |