MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-14 for VIDAS VARICELLA ZOSTER IGG 30217 manufactured by Biomerieux, S.a..
[24713061]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[24713062]
On (b)(6) 2015 a customer in (b)(6) reported a false negative and borderline result using the vidas varicella-zoster igg kit (ref. 30217, lot 1003869180, expiration date 04-jan-2016). The customer repeated the borderline result with an alternate microplate method (dynex dsx) and obtained a positive result. The customer also retested the negative vidas varicella igg result with the dynex method; positive result was obtained. There was no reported adverse event related to the patient's state of health. Biomerieux has initiated internal investigation.
Patient Sequence No: 1, Text Type: D, B5
[34112543]
Biom? Rieux investigation reproduced the results identified by swiss unilabs customer via testing of the fifteen (15) returned samples with vidas? Varicella-zoster igg (vzg), batches 1003869180 and 1004002070. The sample results were determined equivocal or negative. The issue encountered by the customer is not linked with a specific lot. This issue was previously documented based on the results of a comparison study with two other competitor kits. The study concluded there are differences between the three techniques for lower level samples. A large number of equivocal and negative results were observed with vidas? Varicella-zoster igg test. Results of the study (in particular the ratio of equivocal results) are under consideration for future vzg development. As described in the package insert, there is a large "equivocal zone" associated with the vidas? Varicella-zoster igg assay. Results within the eqivocal zone are not considered false results because there is no change of the serological status. Equivocal results should be repeated with a fresh specimen. If it is impractical to obtain a fresh specimen, the assay is repeated with the original specimen. If the sample repeats as an equivocal, the sample should be tested via different method. Vidas? Varicella-zoster igg assay only detects igg and is intended as an aid in the determination of immunological experience with varicella-zoster virus. It's primary use is for vaccination follow-up and is not recommended to isolate igg serology results for the diagnosis of varicella-zoster virus (vzv) infection. As recommended in the package insert, if a definitive determination of vzv immunity is required, patients with negative results should be retested by a more sensitive assay. The investigation determined the vidas? Varicella-zoster igg assay is performing within development specifications in accordance with the defined negative/equivocal/positive zones.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2015-00069 |
| MDR Report Key | 5004773 |
| Date Received | 2015-08-14 |
| Date of Report | 2015-07-24 |
| Date Mfgr Received | 2015-07-24 |
| Date Added to Maude | 2015-08-14 |
| 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, INC |
| Manufacturer Street | 100 RODOLPHE STREET |
| Manufacturer City | DURHAM NC 27712 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27712 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VIDAS VARICELLA ZOSTER IGG |
| Generic Name | VIDAS VARICELLA IGG ASSAY |
| Product Code | LFY |
| Date Received | 2015-08-14 |
| Catalog Number | 30217 |
| Lot Number | 1003869180 |
| Device Expiration Date | 2016-01-04 |
| 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, S.A. |
| Manufacturer Address | CHEMIN DE L ORME MARCY L ETOILE, RHONE 69280 FR 69280 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-14 |