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 2018-07-17 for VIDAS? VARICEL ZOSTER IGG 30217 manufactured by Biomerieux Sa.
[114835671]
A customer in (b)(6) notified biom? Rieux of discrepant results associated with vidas? Varicel zoster igg (reference 30217). The customer reported during the last (b)(6) distribution for immunity screen scheme participants using biom? Rieux vidas assay reported equivocal or negative vzv igg results for specimen (b)(4) that was prepared from a single neat donation and was positive for vzv igg. In pre-distribution testing the specimen was tested positive using diasorin liaison, virion serion, binding site vacczyme quantitative assays. Specimen 4372 was tested equivocal using biom? Rieux vidas? Assay. Readings from pre-distribution and from participants' results show that vzv igg antibodies were present in the specimen. Below references pre-distribution test results for specimen (b)(4): biom? Rieux vidas vzg tv 0. 74 equivocal; diasorin 516. 6 miu/ml (positive cut off 100;) virion serion vzv igg : 300. 58 iu/ml (grey zone 15. 0-20. 0); bonding site vacczyme vzv glycoprotein igg 207 miu/ml (grey zone 100-150). Out of the 93 biom? Rieux vidas? Users 84 (90. 3%) reported an equivocal result, 7 (7. 5%) reported a negative result and one (2. 2%) user reported a positive result for specimen (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2018-00107 |
| MDR Report Key | 7694066 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-07-17 |
| Date of Report | 2018-12-11 |
| Date Mfgr Received | 2018-11-13 |
| Date Added to Maude | 2018-07-17 |
| 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. TIFFANY HALL |
| Manufacturer Street | 100 RODOLPHE STREET |
| Manufacturer City | DURHAM NC 27712 |
| Manufacturer Country | US |
| Manufacturer Postal | 27712 |
| Manufacturer G1 | BIOMERIEUX SA |
| Manufacturer Street | 376 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? VARICEL ZOSTER IGG |
| Generic Name | VIDAS? VARICEL ZOSTER IGG |
| Product Code | LFY |
| Date Received | 2018-07-17 |
| Catalog Number | 30217 |
| 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 | 376 CHEMIN DE L ORME MARCY L ETOILE, RHONE 69280 FR 69280 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-17 |