MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-01 for VIDAS? VARICELLA IGG 30217 manufactured by Biomerieux Sa.
[107702704]
A customer in the (b)(6) notified biom? Rieux of discrepant results associated with vidas? Varicella (igg) (reference 30217). The customer reported running three (3) patient samples using a new lot of product and the results were: 1 negative, 1 equivocal and 1 positive. The results for sample no. (b)(4) during the week of (b)(6) 2018 on the old lot were reported as 3. 18. Yesterday ((b)(6) 2018) using new lot the result was 3. 92 and 3. 25 while running the sample on the old lot. The results for sample no. (b)(4) during the week of (b)(6) 2018 on the old lot were reported as 0. 12. Yesterday ((b)(6) 2018) using new lot the result was 0. 14 and 0. 13 while running the sample on the old lot. The results for sample no. 184027728 during the week of 26mar2018 on the old lot were reported as 0. 80. Yesterday (04apr2018) using new lot the result was 1. 05 and 0. 91 while running the sample on the old lot. The customer is concerned with results for sample (b)(4). The sample was reported last week as an equivocal result with a value of 0. 80. Yesterday ((b)(6) 2018) on the new lot the results obtained were 1. 05. The customer is concerned that equivocal results could be reported as positives using the new lot when compared to the previous lots. The customer reported these discrepant results lead to a delay of greater than 24 hours. There is no known impact to the patient due to the discrepant and delayed results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2018-00061 |
| MDR Report Key | 7476873 |
| Date Received | 2018-05-01 |
| Date of Report | 2018-07-24 |
| Date Mfgr Received | 2018-06-27 |
| Device Manufacturer Date | 2017-12-13 |
| Date Added to Maude | 2018-05-01 |
| 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 | 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, 69280 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 69280 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VIDAS? VARICELLA IGG |
| Generic Name | VIDAS? VARICELLA IGG |
| Product Code | LFY |
| Date Received | 2018-05-01 |
| Catalog Number | 30217 |
| Lot Number | 1006161020 |
| Device Expiration Date | 2018-09-26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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, 69280 FR 69280 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-01 |