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 2016-03-15 for VIDAS? LYME IGG 30320 manufactured by Biomerieux Sa.
[40352391]
A customer in (b)(6) reported a false negative result while using product; vidas lyme igg test kit. There were no reports of patient harm.
Patient Sequence No: 1, Text Type: D, B5
[46134775]
A customer in (b)(6) reported a false negative result while using product; vidas lyme igg test kit. An internal biom? Rieux investigation was performed with results as follows: no additional complaints for vidas lyme igg test kit lot 1004350980/160914-0 since january 2015. Analysis of batch history records indicates there was no anomaly detected during the control process. Tested one (1) negative sample and three (3) positive samples on the retained vidas lyme igg test kit lot 1004350980. Results- results obtained for the four (4) samples, were within specifications. Analysis of the control card for these four (4) samples show that vidas lyme igg lot 1004350980 is in trend with other lots. Western blot test igg result- there were only three (3) positive bands with two (2) representing early markers (p41 and ospc). On the western blot test igm, there were five (5) positive bands with four (4) representing early markers (ospc). Vidas- negative control result (c2 ) was 0. 00 vt while the sample result was 0. 10 vt with a low detection, which may represent an early infection with igg present but at a rate too low to be detected positive; however, at a sufficiently high rate to be detected by western blot, which is a more sensitive method. Per the vidas lyme igg package insert, antibody detection methods do not provide definitive results for establishing or ruling out a diagnosis of lyme borreliosis. A negative result in the vidas lyme igm and vidas lyme igg assays does not rule out the possibility of b. Burgdorferi infection in a patient. Patients in early stages of infection or who have undergone antibiotic therapy, may not produce measurable igm and igg. Patients with clinical history and/or symptoms suggestive of lyme disease, but with negative test results, should be reported as "no detectable antibodies to b. Burgdorferi. " a second specimen should be collected in 4-6 weeks. It is estimated that in 50% of subjects, in the primary stage of disease, antibody levels in blood remain below the detectable threshold. Conclusion- vidas lyme igg test kit is performing within acceptable limitations as noted in the package insert.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2016-00055 |
| MDR Report Key | 5501162 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-03-15 |
| Date of Report | 2016-03-09 |
| Date Mfgr Received | 2016-03-09 |
| Date Added to Maude | 2016-03-15 |
| 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 | MR. RYAN LEMELLE |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147318582 |
| Manufacturer G1 | BIOMERIEUX SA |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | ST. LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63042 |
| 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 | 2016-03-15 |
| Catalog Number | 30320 |
| Lot Number | 1004350980 |
| Device Expiration Date | 2016-09-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2016-03-15 |