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 2016-02-02 for VIDAS? LYME IGG 30320 manufactured by Biomerieux Sa.
[37342669]
An investigation into the false negative event was performed by biomerieux. The returned patient samples were analyzed on 2 lots of vidas? Lyme igg as well. The results of this testing found the sample to be negative for lyme igg. Further testing was performed on lia- liaison-diasorin (boreliose serology) and all-diag lyme check. The results of both of those confirmatory tests were also negative for lyme igg, confirming the vidas? Lyme igg result. Additionally, the batch production record was reviewed. No anomalies were found that would have contributed to this event. Based on the investigation, the performance of vidas? Lyme igg tests are within specifications and cannot confirm the customer's result.
Patient Sequence No: 1, Text Type: N, H10
[37342670]
A customer in (b)(6) reported to biomerieux that they have observed discrepant results when the vidas lyme igg test. One patient was tested three times. The three samples were determined negative on vidas igg. A confirmatory test by western blot bioadvance was positive for lyme igg. The patient was previously diagnosed as positive for ankylosing spondylitis and polyarthralgia. When specifically requested, the customer indicated there was no impact to patient or patient treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2016-00030 |
| MDR Report Key | 5404862 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-02-02 |
| Date of Report | 2015-12-01 |
| Date Mfgr Received | 2015-12-01 |
| Date Added to Maude | 2016-02-02 |
| 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 | CHEMIN DE L ORME |
| Manufacturer City | MARCY L ETOILE, RHONE 69280 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 69280 |
| 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 | 2016-02-02 |
| Returned To Mfg | 2015-12-29 |
| Catalog Number | 30320 |
| Lot Number | 1004145040 |
| Device Expiration Date | 2016-06-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2016-02-02 |