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 2018-11-13 for VIDAS? LYME IGG 30320 manufactured by Biomerieux Sa.
[129161818]
A customer in (b)(6) reported false negative results in association with the vidas? Lyme igg assay ( lot 1006571330). On (b)(6) 2018, the customer received a cerebrospinal fluid (csf) sample to test for neuroborreliosis. They also asked the neurologist for serum (blood) to test for intrathecal igg synthesis. The vidas lyme igg test was performed on both samples (csf and blood), and both results were negative. The blood sample was negative with an index at 0. 15, and the csf sample had an index at -0. 02, with intrathecal igg antibody production index (iap) obtained at 0. The csf did not indicate any sign of inflammation (normal number of lymphocytes, normal total protein). Therefore the customer concluded that there was no intrathecal synthesis of lyme igg antibodies. The neurologist then sent the samples to a private laboratory: both samples were positive twice with the liaison? Vlse (variable major protein-like sequence expressed) method. The first sample was obtained at 20 au/ml and the consecutive sample was obtained at 40 au/ml (positive as off 10-15 au/ml). The customer also tested the sample with vidas lyme igm and the result was positive. A western blot assay was performed for both igg and igm, and both 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 | 3002769706-2018-00238 |
| MDR Report Key | 8065985 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-11-13 |
| Date of Report | 2018-11-13 |
| Date of Event | 2018-10-09 |
| Date Mfgr Received | 2018-10-18 |
| Device Manufacturer Date | 2018-06-14 |
| Date Added to Maude | 2018-11-13 |
| 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. DEBRA BROYLES |
| 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 | 2018-11-13 |
| Catalog Number | 30320 |
| Lot Number | 1006571330 |
| Device Expiration Date | 2019-05-30 |
| 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 | 2018-11-13 |